RTOG - Member Update

Member Update

FUTURE MEETINGS:

June 19-22, 2008 at Loews Philadelphia Hotel, Philadelphia, Pennsylvania
January 15-18, 2009 at Sheraton New Orleans Hotel, New Orleans, Louisiana
June 25-28, 2009 at Chicago Marriott Downtown, Miracle Mile, Chicago, Illinois
January 14-17, 2010 at Tampa Marriott Waterside, Tampa, FL
June 17-20, 2010 at Loews Philadelphia Hotel, Philadelphia, PA

DATE: July 24, 2008

SUBJECT: RTOG 0127/ECOG E5597: ECOG Protocol Amended

RTOG sites participating in RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer"

ECOG has amended the protocol. NOTE: RTOG sites can access the Addendum #7 via a link to ECOG's web site, http://www.ecog.org/rtog/ (User name: rtog and Password: igprot). On ECOG's web site, scroll down to ECOG 5597.

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Per the ECOG Coordinating Center: Addendum #7 contains administrative changes only and, per OHRP guidelines, expedited IRB review may be appropriate. However, please consult your local IRB's policy, since their requirements may differ and require full board review. This addendum must be submitted and reviewed by your IRB within 90 days of receipt of this notice, unless your local IRB has different written SOPs, which must be available at future ECOG audits.

Addendum #7 includes the following changes:
Please note: Changes 3-5 are due to an increased Recommended Daily Allowance for selenium.
1. Title Page: Changed the version date. Removed the following: "The text of this protocol incorporates Addendum #1, Addendum #2".
2. Contact Information Page: Replaced Danielle M. Coute with Jeanne Riddle as the Study Chair Liaison.
3. Section 3.171, Page 7a: Changed "…> 50 mcg selenium…" to "…>70 mcg selenium…"
4. Section 3.172, Page 8: Changed "…< 50 ?g selenium" to "…< to 70 ?g selenium"
5. Section 3.173, Page 8: Changed "…> 50 ?g selenium…" to "…>70 ?g selenium…"
6. Section 7.1, Page 26, Table: In row "Supplement/Alcohol/Tobacco Usage Assessment", column
"Step 2 Study Phase Prior to Randomization" deleted the "X" as there is no requirement for these assessments at this time point. Deleted footnote number 4.
7. Appendix 1, Page 1: Changed the version date.
8. Appendix 1, Page 2: In the 3rd bullet under "Procedures" the Paragraph was rewritten as follows:
"You will be asked to complete a questionnaire on which you will provide a detailed history of supplement, tobacco, and alcohol use every six months until the end of your treatment."
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Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: July 24, 2008

SUBJECT: RTOG 0525, Updated

Updated

RTOG 0525, "Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma," Update: Contact information was updated for the RTOG Biospecimen Resource and Biologics, Inc.

Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0525/summary_changes.html

Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0525/0525.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses. IRB review of an update is not required; however, these changes must be reported to site IRBs.

Please notify your affiliates that are not on e-mail.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 23, 2008

SUBJECT: Form Revision Notice - RTOG 0518

RTOG 0518
Phase III randomized trial to evaluate the efficacy of Zometa® for the prevention of osteoporosis and associated fractures in patients receiving radiation therapy and long term LHRH agonists for high-grade and/or locally advanced prostate cancer

Forms Revision

The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0518/main.html

The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
A5	A5 7/22/08
I1	I1b 7/22/08
TF	TFa 7/22/08
DA	DAc 7/22/08
F1	F1a 7/22/08
PQ	PQa 7/22/08
HP	HPa 7/22/08
T1	T1a 7/22/08

Changes Made: Title changed to reflect dropping the placebo arm.

Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after August 1, 2008 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Roseann Bonanni, CCRP
RTOG Research Associate

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 22, 2008

SUBJECT: Web Data Submission Update

Web-Based Electronic Data Submission is now available for the following forms:

RTOG 0522 I1 - Initial Evaluation Form
RTOG 0630 F1 - Follow-Up Form

Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html

For technical support with web data submission, please email websupport@phila.acr.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

Please Note: Minor changes have been made to the paper versions of these forms to facilitate web data submission and the RTOG web site has been updated with the most recent versions which are:

RTOG 0522 I1 Initial Eval. Form I1b 7-22-08
RTOG 0630 F1 Follow-up Form F1c 7-22-08

Web registration is available 24/7. Information and instructions are at http://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 22, 2008

SUBJECT: RTOG 0518 News

Please see the news below regarding RTOG 0518, A Phase III Randomized Trial To Evaluate The Efficacy Of Zometa® For The Prevention Of Osteoporosis And Associated Fractures In Patients Receiving Radiation Therapy And Long Term LHRH Agonists For High-Grade And/Or Locally Advanced Prostate Cancer.

RTOG 0518
PROTOCOL FOR PATIENTS ON LHRH AGONIST FOR AT LEAST ONE YEAR

BIG NEWS
Patients randomized to: VIT D & CA++ VS VIT D & CA++ & Q 6 months ZOMETA

AMENDMENTS APPROVED
Placebo arm is eliminated and Q 3 months ZOMETA has been changed to Q 6 months administration

EASIER ACCRUAL
Extra funding for this study is unchanged despite fewer doses of Zometa and no placebo arm

FINAL REMINDER
Patients on RTOG 0521, "A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer," are also eligible for this trial if they are randomized to the no-chemo arm of 0521

DATE: July 22, 2008

SUBJECT: RTOG 0424, Amended

Amended RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," Amendment # 4. Note: This change was made previously; it was a change included in an Update that was broadcast on 2/27/07. Subsequently, NCI reviewed the Update and required that this particular change be submitted as an amendment.

Please see the complete summary of changes at http://www.rtog.org/members/protocols/0424/summary_changes.html

Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/active.html

NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. The "Update Date" indicates that administrative/editorial changes were made to the protocol.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: July 18, 2008

SUBJECT: RTOG 0517: Important Information About Radioisotopes and Chemotherapy

Attention Investigators Thinking of Enrolling Patients on RTOG 0517
Please read the attached letter from Michael Seider, MD, Principal Investigator of RTOG 0517 regarding the use of radioisotopes and chemotherapy on this trial.

0517 Seider letter to investigators_7-18-08.doc

DATE: July 18, 2008

SUBJECT: Web-Based Electronic Data Submission Update

Web-Based Electronic Data Submission is now available for the following form:

RTOG 0232 F1
Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html

For technical support with web data submission, please email websupport@phila.acr.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 18, 2008

SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE

******Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information***

RTOG has received safety report(s) from Schering-Plough for Temozolomide

The Following RTOG studies also involve Temozolomide:

RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)

RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS"

RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA"

RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"

RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME"

RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"

RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME"

RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

The safety report(s) are sent automatically to the sites that have patients enrolled in the study.

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- 2007SP018230 FU8.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 18, 2008

SUBJECT: RTOG (0324), (0234), 0522, & 0436 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr284.pdf
- erbitux-ib12-esr285.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 18, 2008

SUBJECT: RTOG ACR Fellowship for Radiation Oncology Research

RTOG Accepting Applications for the RTOG ACR Radiation Oncology Resident Training Fellowship

The Radiation Therapy Oncology Group (RTOG), with support from the American College of Radiology (ACR), has established a Radiation Oncology Resident Training Fellowship. This five-day fellowship at RTOG Headquarters in Philadelphia will focus on introducing residents to radiation oncology research. The RTOG Fellows will participate in a two-day RTOG Study Chair Education and Training Session and a subsequent three-day program designed by the resident and RTOG leadership and staff to investigate more fully his or her area of interest in radiation oncology research.

Residents interested in applying for the Fellowship must submit an application, including a CV and a brief narrative describing the intended focus of their three-day session. The intended area of focus can be a disease site (RTOG's principal disease sites are: brain, bladder, cervix, breast, head & neck, prostate, and GI sites), an RT treatment modality (IMRT, brachytherapy, stereotactic, 3DCRT), or revolve around an outcomes or translational research question. RTOG staff will help successful applicants finalize their research focus. Participation of the resident's home institution as an RTOG member will also be considered during the application review. Each Fellow will also be required to submit a brief review of the value of the experience and a critique of the program at the conclusion of the Fellowship.

The ACR, working with RTOG, will provide for reasonable reimbursement of travel, room and board. RTOG will award two Fellowships for each Study Chair Education and Training Session. The remaining session for 2008 is September 15 - 19. The first of the 2009 sessions is expected to be held March 16 - 20, 2009.

Applications are due at RTOG Headquarters by July 31, 2008. Applications and information about RTOG's research areas are available on the RTOG Web site at www.rtog.org.

For additional information please contact Steven King, Assistant Executive Director, American College of Radiology, Philadelphia Office, by email: sking@phila.acr.org or telephone: 215.574.3218.

DATE: July 17, 2008

SUBJECT: RTOG 0415

Amended RTOG 0235/ACRIN 6668, "Positron Emission Tomography Pre- and Post-treatment Assessment for Locally Advanced Non-small Cell Lung Carcinoma," Amendment 6

Note: This study is coordinated by ACRIN. Please ACRIN's e-mail and attachments below.

If you have any questions about this amendment, please contact Martha L. Heckel, ACRIN Protocol Associate (contact information below)

Please notify your affiliates that are not on e-mail.

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Dear ACRIN 6668/RTOG 0235 Principal Investigators and Research Associates:

The NCI/CTEP has approved Amendment 6 for ACRIN 6668 (version date July 11, 2008).

Attached are:
1) The final amended protocol
2) The final version of the protocol with all changes tracked
3) A summary of changes describing the modifications made in amendment 1
4) A Microsoft Word version of the informed consent
5) CTEP's approval letter.

Please submit the amended protocol to your IRB within 60 working days from today. Please contact your IRB coordinator for guidance and for your IRB's policies on the type of review and approval needed for amendments.

You are required to conduct the protocol under the current IRB-approved protocol (version date August 15, 2007) until your IRB approves Amendment 6. Once you have received approval from your IRB, please fax the IRB approval letter and the revised consent form to my attention at the fax number listed below. Please include your name, the ACRIN study number (6668), your ACRIN site number, and the amendment number/protocol version date.

Please feel free to contact me with any questions.

Best regards,

Martha

Martha L. Heckel, Protocol Associate
ACRIN Protocol Development and Regulatory Compliance
1818 Market Street, Suite 1600
Philadelphia, PA 19103
Phone: 215-574-3169
Fax: 215-717-0936
E-mail:

- PACRIN-6668 A07Approval01.pdf
- ACRIN6668_Amend6_master_071108.pdf
- ACRIN6668_Amend6_highlighted_071108.pdf
- SOC-ACRIN 6668_Amendment_6,_7.11.08.pdf
- Informed_Consent-ACRIN_6668.doc

DATE: July 16, 2008

SUBJECT: RTOG 0415

FOR INVESTIGATORS ON RTOG 0415

July 16, 2008

Dear RTOG Colleagues:

Thank you for your continued efforts accruing participants to RTOG 0415. The first patient was registered in June 2006 and in barely two years, 500 men have been entered on study! The study is designed to enroll 1067 men and we should reach that level, with your continued help, by the summer of 2010.

Again, many thanks to all of you. Please feel free to contact me if you have any questions or suggestions to improve accrual.

W. Robert Lee, MD
w.robert.lee@duke.edu

DATE: July 15, 2008

SUBJECT: RTOG 0521, Amended

Amended
RTOG 0521, A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer:

Amendment 4: In Section 6.0, target volume definitions and contouring instructions were clarified. In Section 10.0, the new contact information for the RTOG Biospecimen Resource was added.

Please see the complete Summary of Changes for the amendment at: http://www.rtog.org/members/protocols/0521/summary_changes.html

You may download a copy of the protocol for IRB review by accessing the RTOG web site at: http://www.rtog.org/members/protocols/0521/0521.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. The "Update Date" indicates that administrative/editorial changes were made to the protocol. IRB review of the update is not required; however, this change must be reported to site IRBs.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence.

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: July 15, 2008

SUBJECT: Web-Based Electronic Data Submission Update

Web-Based Electronic Data Submission is now available for the following form:

RTOG 0615 I1 - Initial Evaluation Form

Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html

For technical support with web data submission, please email websupport@phila.acr.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

DATE: July 15, 2008

SUBJECT: RTOG 0614, Updated

Updated
RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy" has been updated to clarify drug ordering information.

Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0614/summary_changes.html

Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0614/0614.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: July 11, 2008

SUBJECT: RTOG (0324), (0234), 0522, & 0436 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr277-fu01.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 11, 2008

SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE

***Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information***

RTOG has received safety report(s) from Schering-Plough for Temozolomide

The Following RTOG studies also involve Temozolomide:

RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)

RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS"

RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA"

RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"

RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME"

RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"

RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME"

RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

The safety report(s) are sent automatically to the sites that have patients enrolled in the study.

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- 2008SP010385 FU1.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 10, 2008

SUBJECT: Web-Based Electronic Data Submission Update

Web-Based Electronic Data Submission is now available for the following forms:

RTOG 0232 FS
RTOG 0621 TF

Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html

For technical support with web data submission, please email websupport@phila.acr.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

DATE: July 8, 2008

SUBJECT: RTOG 0424, Amended and Re-opened

Amended and Re-opened
RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," Amendment # 3 to re-open the study with an increased sample size. The study is re-opened to accrual effective immediately.

Please see the complete summary of changes at http://www.rtog.org/members/protocols/0424/summary_changes.html

Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/active.html

NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Since additional risks were added, RTOG recommends reconsenting patients on this trial but your local IRB will have the final authority.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: July 7, 2008

SUBJECT: Form Revision Notice - F1/FS Revisions on Multiple Studies

Form Revision
Multiple RTOG Studies
F1/FS revisionr
The following forms have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/list.html The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
522F1	522F1c 7-3-08
822F1	822F1a 6-26-08
630F1a	630F1b 6-26-08
623F1	623F1a 6-26-08
618F1	618F1a 6-26-08
617F1a	617F1b 6-26-08
615F1b	615F1c 6-26-08
529F1	529F1a 6-26-08
438F1c	438F1d 6-26-08
435FSb	435FSc 6-26-08
435F1b	435F1c 6-26-08
421F1	421F1a 7-2-08
418F1	418F1a 6-26-08
417F1	417F1a 6-26-08
411F1a	411F1b 6-26-08
330F1a	330F1b 6-26-08
247F1b	247F1c 6-26-08
234F1b	234F1c 7-1-08

Changes Made: These all involved changes to the Progression and/or New Primary Tables.

Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after July 15, 2008 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Wendy Bergantz, RN

RTOG Data Management

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: July 2, 2008

SUBJECT: RTOG (0324), (0234), 0522, & 0436 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

***Please Note: erbitux-ib12-esr277-fu01 is indeed a follow-up though the MEDWatch form lists the report as an initial report. This information has been confirmed by BMS. Please make a note of this information. Thanks***

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr281-fu01.pdf
- erbitux-ib12-esr277-fu01.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 30, 2008

SUBJECT: RTOG 0436, Activated

Activated
RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0436/0436.pdf

Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0436/main.html

Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0436/summary_changes.html.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: June 27, 2008

SUBJECT: RTOG 0513 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Motexafin Gadolinium/Xcytrin

RTOG has received safety report(s) from NCI for Motexafin Gadolinium/Xcytrin

The Following RTOG studies involve Motexafin Gadolinium/Xcytrin:

RTOG 0513, "A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme,"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- Xcytrin AE-1499110 Protocol ACNS0222 No 1.pdf

DATE: June 27, 2008

SUBJECT: RTOG Holiday Registration Desk Hours

The RTOG Registration Desk will close for the Independence Day Holiday Weekend at 3 PM on Thursday, July 3, 2008 and will reopen on Monday, July 7, 2008 at 8:30 AM.

Studies utilizing web registration will remain available.

DATE: June 26, 2008

SUBJECT: RTOG 0518, Amended and Updated

Amended and Updated

RTOG 0518, A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Amendment 5 changes include: Revised language in Section 7.0 regarding treatment assignment unblinding and re-assignment of cases on study, and notification to institutions.

Update: Drug shipment details were clarified in Section 7.0.

Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0518/summary_changes.html

You may download a copy of the Protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0518/0518.pdf.

NCI policy requires that the "Version Date" on the Protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days.

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: June 19, 2008

SUBJECT: RTOG 0525, 1st-Step Registration CLOSED

ATTENTION RTOG 0525 INVESTIGATORS
RTOG 0525, "Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma," CLOSED to patient accrual (1st step registration) at 5 PM EST on June 13.

2nd Step Registration is OPEN to allow patients who were registered by the deadline to enter the randomization stage of the trial.

As of 5 PM EST June 13, NO PATIENTS may be registered to 1st Step Registration (the pre-randomization stage).

DATE: June 18, 2008

SUBJECT: GU Studies Undergoing Analysis - RTOG 9408, 9601 and 0233

ATTENTION!! ATTENTION!! ATTENTION!!
The following GU studies will be undergoing analysis in the near future. In order to prepare the data for these analyses, it is necessary to request that the following time lines be observed:

RTOG 9601 &rarr all data due through March 31, 2008 must be received at Headquarters by September 30, 2008. The follow up form for this study is available for web data entry.

RTOG 0233 &rarr all data due through September 30, 2008 must be received at Headquarters by November 30, 2008.

RTOG 9408 &rarr all data due through December 31, 2008 must be received at Headquarters by February 15, 2009. The follow up form for this study is available for web data entry.

In order to know which data are outstanding, please use the Calendar Ops Tool. This tool is located on the RTOG website homepage &rarr Site Tools &rarr Ops Tool. The Ops Tool Manual (instruction manual) is attached for your reference. If you have any questions about this request, please contact Elaine Motyka-Welsh at emotyka@phila.acr.org or 215-574-3216.

- Ops Tool User Doc v2 0.pdf

DATE: June 18, 2008

SUBJECT: Proton Symposium at RTOG Semiannual Meeting

Attached is the agenda for the symposium, Proton Therapy in the Cooperative Group Setting, that will take place on June 20, 2008 at the RTOG Semiannual Meeting in Philadelphia. The agenda is also available at the RTOG Web site at:

http://www.rtog.org/meeting/Proton_Symposium_June_08.pdf

DATE: June 17, 2008

SUBJECT: RTOG 0614, Updated

Updated

RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy" has been updated.

Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0614/summary_changes.html

Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0614/0614.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: June 16, 2008

SUBJECT: RTOG 0436, Posted For Site IRB Approval/Pre-Registration Requirements

REMINDER: Pre-Activation Notification

RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery," was approved by the NCI on April 17, 2008.

RTOG will activate this study (open it for patient enrollment) on June 30, 2008. RTOG will broadcast on that date to notify institutions that the study is open to accrual. The study is approved for 1.0 CTEP treatment credits and 0.5 DCP cancer control credits.

IMPORTANT: Institutions should be downloading and submitting the protocol for submission to their local IRBs in advance of the June 30 activation. If you are a member of the CIRB, please process your facilitated review.

Institutions should also be completing the pre-registration requirements for 3D-CRT (See Section 5.1 of the protocol) in advance of the June 30 activation.

Institutions can access a copy of the NCI-approved protocol for IRB review on the RTOG website at http://www.rtog.org/members/protocols/0436/0436.pdf

The protocol summary, a one-page overview of the study, is located on the RTOG website at http://www.rtog.org/summaries/gi.html

The case report forms are available on the RTOG website at http://www.rtog.org/members/forms/0436/main.html

Please notify your affiliates who are not on e-mail

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 13, 2008

SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE

RTOG has received safety report(s) from Schering-Plough for Temozolomide

The Following RTOG studies also involve Temozolomide:

RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)

RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS"

RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA"

RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"

RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME"

RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"

RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME"

RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

The safety report(s) are sent automatically to the sites that have patients enrolled in the study.

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- 2008SP009832 Initial.pdf
- 2008SP010385 Initial.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 13, 2008

SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB

RTOG has received safety report(s) from NCI for BEVACIZUMAB

The Following RTOG studies involve BEVACIZUMAB:

RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER"

RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA"

RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- Bevacizumab AE-1653936 Protocol GOG-0218 No 2.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

Please notify your affiliates who are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 13, 2008

SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr282.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

Please notify your affiliates that are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 13, 2008

SUBJECT: RTOG 0525, Closure

Closure

RTOG 0525, "Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma," will close to patient accrual at 5 PM EST today, because it has met its accrual objective. Notice of this closure was previously broadcast on May 8, 2008.

2nd Step Registration will remain OPEN to allow patients registered by 5 PM EST today to enter the randomization stage of the trial.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: June 12, 2008

SUBJECT: RTOG 0132, 0212, 0330, and 0615: Updated

UPDATED

RTOG 0132/ACRIN 6665 (ECOG R0132), "A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (GLEEVEC NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117) [ACRIN 6665]", (a closed study), Updated: Contact information for Dr. Blanke and for the RTOG Biospecimen Resource

RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer" (a closed study), Updated: The SWOG Co-Chair

RTOG 0330, "A Pilot Phase II Study of Pre-Operative Radiation Therapy and Thalidomide (IND 48832; NSC 66847) for Low Grade Primary Soft Tissue Sarcoma or Pre-Operative MAID/Thalidomide/ Radiation Therapy For High/Intermediate Grade Primary Soft Tissue Sarcoma of the Extremity or Body Wall (a closed study)", Updated: Contact information for Dr. Kraybill and for the RTOG Biospecimen Resource

RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer", Updated: Question 9 on the Eligibility Checklist

Sites can access the complete summaries of changes at:
http://www.rtog.org/members/protocols/s0132/summary_changes.html
http://www.rtog.org/members/protocols/0212/summary_changes.html
http://www.rtog.org/members/protocols/0330/summary_changes.html
http://www.rtog.org/members/protocols/0615/summary_changes.html

Sites can download a copy of the updated protocols by accessing the RTOG web site at http://www.rtog.org/members/numericactive.html

NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses on the summary of changes. IRB review of an update is not required; however, these changes must be reported to site IRBs.

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

DATE: June 10, 2008

SUBJECT: Form Revision

Form Revision
RTOG # 0529
Phase II Evaluation IMRT & Chemotherapy in Carcinoma of the Anal Canalr
Forms Revision
The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0526/0526t1.pdf

The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
T1 Radiotherapy Form	T1a 5/30/2008

Discard obsolete versions and commence use of the revised edition immediately. This form will be available for Web Data Entry.

Please notify your joint center institutions and affiliates who are not on e-mail.

Per previous Broadcasts, Web-based data submission for available forms became mandatory as of May 14, 2007 for all cases enrolled through RTOG. A complete listing of all available web-based data collection forms is located at http://www.rtog.org/members/webreg.html

Beginning Tuesday, May 27, 2008, all paper data collection forms received from RTOG member institutions at RTOG Headquarters which are available for web-based data submission will be returned to your institution. These paper forms will not be credited to patients’ calendar and will need to be re-submitted via the web.

For technical support with web data submission, please email websupport@phila.acr.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

DATE: June 10, 2008

SUBJECT: Form Revision

Form Revision
RTOG # 0526
Phase II Locally Recurrent Prostate Brachytherapy Following External Beamr
Forms Revision
The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0526/0526t1.pdf

The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
T1 Radiotherapy Form	T1a 5/30/2008

DATE: June 10, 2008

SUBJECT: Form Revision Notice

Form Revision
RTOG # 0521
Phase III Randomized Study of Localized, High-Risk Prostate Cancer
Forms Revision
The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0521/0521t1.pdf

The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
T1 Radiotherapy Form	T1a 5/30/2008

DATE: June 9, 2008

SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE

****Please Note****

Safety Report 2008SP009302 is a re-broadcast. There is newly added information to the attached report. This report replaces the Safety Report broadcast initially on 5/29/2008.

RTOG has received safety report(s) from Schering-Plough for Temozolomide

The Following RTOG studies also involve Temozolomide:

RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)

RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS"

RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA"

RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"

RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME"

RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"

RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME"

RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

The safety report(s) are sent automatically to the sites that have patients enrolled in the study.

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- 2008SP009306 FU1.pdf
- 2008SP009302 Initial Update.pdf
- 2008SP003086 FU1.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 9, 2008

SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB

RTOG has received safety report(s) from NCI for BEVACIZUMAB

The Following RTOG studies involve BEVACIZUMAB:

RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER"

RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA"

RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- Bevacizumab AE-1653936 GOG-0218 - 1.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

Please notify your affiliates who are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 9, 2008

SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

****Please note*****

Corrected DDL to ESR#264 is a re-broadcast of a previous report. The attached memorandum serves to correct an entry error noted on the cover letter to DDL#264 which was initially broadcast on 2/15/08.

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr281.pdf
- Corrected DDL to ESR 264 (2).pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

Please notify your affiliates who are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: June 9, 2008

SUBJECT: RTOG 0417 Optional Imaging Component

Reminder to sites participating in RTOG Protocol 0417:
RTOG Protocol 0417: A Phase II Study of Bevacizumab in Combination with Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients with Locally Advanced Cervical Carcinoma includes an OPTIONAL COMPANION IMAGING COMPONENT which offers extra RTOG case credit.

This optional study is listed in protocol 0417 as Appendix VIII: 'Proposal for Image-Based Intracavitary Bracytherapy for Cervical Carcinoma' on page 65.

Participation in this image submission registry study will result in the earning of 0.5 RTOG extra case credit in addition to the 1.0 RTOG case credit for protocol 0417 case enrollment.

Please read this image submission proposal titled Appendix VIII and contact Dr. Beth Erickson at BErickson@mcw.edu for further assistance and clarification.

DATE: June 6, 2008

SUBJECT: RTOG 0438, Temporarily Closed Effective Immediately

Temporarily Closed

RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases," is temporarily closed effective immediately for the protocol-specified toxicity evaluation of dose level III (4.5 Gy/fx for a total of 45 Gy).

We apologize for any inconvenience with respect to patients currently being worked up for this trial, but as safety is the primary endpoint, this temporary closure must take place immediately.

Please notify your affiliates who are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration and Web-based data submission are available 24/7.

DATE: June 4, 2008

SUBJECT: Web-Based Electronic Data Submission Update

Web-Based Electronic Data Submission is now available for the following forms:

RTOG 0232 I1 & RTOG 0621 F1
Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html

For technical support with web data submission, please email websupport@phila.acr.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.

Web registration and Web-based data submission are available 24/7.

DATE: May 30, 2008

SUBJECT: Form Revision Notice - RTOG 0630

Form Revision
RTOG 0630
Phase II Sarcoma
The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0630/0630tf.pdf The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
TF Treatment Summary Form	TFa 5-30-08

Changes:
Question 13: Added for collection of lab values in Standard International Units.

Discard obsolete versions and commence use of the revised edition immediately. This form will be available for Web Data Entry.

Please notify your joint center institutions and affiliates who are not on e-mail.

Linda Messett, RN
RTOG Data Management

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 29, 2008

SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB

RTOG has received safety report(s) from NCI for BEVACIZUMAB

The Following RTOG studies involve BEVACIZUMAB:

RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER"

RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA"

RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- Bevacizumab Investigator Notification Genentech MFR 253621- May 20 2008.pdf
- Bevacizumab Investigator Notification Genentech MFR 257028 - May 20 2008.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

Please notify your affiliates who are not on e-mail.

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 29, 2008

SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE

RTOG has received safety report(s) from Schering-Plough for Temozolomide

The Following RTOG studies also involve Temozolomide:

RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)

RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS"

RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA"

RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES"

RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME"

RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"

RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME"

RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"

RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA”

The safety report(s) are sent automatically to the sites that have patients enrolled in the study.

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- 2007SP018230 FU7.pdf
- 2007SP007552FU9.pdf
- 2008SP009306.pdf
- 2008SP009302.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 29, 2008

SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB

RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB

The Following RTOG studies involve CETUXIMAB:

RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)"

RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK"

RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS"

Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file.

- erbitux-ib12-esr 280.pdf

Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html

If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 28, 2008

SUBJECT: Form Revision Notice - RTOG 0232

Form Revision
TOG 0232
Phase III Prostate

The following form for this study has been revised. Download the new version from the RTOG web site athttp://www.rtog.org/pdf_forms.html?members/forms=0232/0232i1.pdf

The edition code for case report forms is found in the lower right corner of the form.

Form Type	New Version Code/Date
I1 Initial Evaluation Form	Ila 5-27-2008

Changes:
Question 3A: Revised to code table format of data entry
Question 5A: Other specify was revised to accommodate character data entry in anticipation of web data entry.

Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after June 6, 2008 will be returned to the site for transcription.

Please notify your joint center institutions and affiliates who are not on e-mail.

Elaine Motyka-Welsh, RN, MSN, CCRP
RTOG Research Associate

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 23, 2008

SUBJECT: T5 Submission to RTOG Headquarters

Effective Immediately please forward T5 (Daily Treatment Record)
on all Advanced Technology RTOG Protocols (per section 12.0) to
BOTH
* ITC * (Image-guided Therapy Center)
AND
Send copy of T5 to RTOG Headquarters
Attn: RTQA
1818 Market Street, Suite 1600
Philadelphia, PA 19103

Amendment for data submissions of T5 for all active RTOG protocols will be forthcoming.

Please contact RTOG RTQA Department with any questions at 215-574-3219

DATE: May 22, 2008

SUBJECT: RTOG 0617, Updated

Updated

RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer," Update:

Logistics for storage and shipping of buffy coat specimens;
Contact information for the RTOG Biospecimen Resource; and
CTSU registration hours

Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0617/summary_changes.html

Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0617/0617.pdf

NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses. IRB review of an update is not required; however, these changes must be reported to site IRBs.

Please notify your affiliates that are not on e-mail.

To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org.

Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html

DATE: May 22, 2008

SUBJECT: RTOG 0233, Amended

Amended

RTOG 0233, "A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy":

Amendment 5: In the sample consent, the timing of the drug and radiation treatments was revised for consistency with Section 7.1.6 of the protocol. The Schema table was reformatted