0834 Broadcast S DATE: August 31, 2010 SUBJECT: RTOG 0436, 0521,0525 0617,0619, 0831, 0834, 0920, 0929 DRUG Distributor Biologics Holiday Closure Notice Biologics Clinical Trial Services is closed Monday, September 6, 2010, for the Labor Day holiday. We will resume regular business hours on Tuesday, September 7. If you have questions or need to coordinate shipments in advance, please don¡¦t hesitate to contact your Clinical Trial Project Manager at 800-693-4906. Katie Reitzel Clinical Trial Project Manager kreitzel@biologicstoday.com Ext. 4993 Elliott Lee Clinical Trial Project Manager elee@biologicstoday.com Ext. 4990 Karl Buer Manager, Sales and Operations Kbuer@biologicstoday.com Ext. 4991 DATE: May 27, 2010 SUBJECT: Protocol Notice: RTOG 0436, 0521,0525 0617,0619, 0831, 0834,0920 DRUG Distributor Biologics Holiday Closure Notice Biologics Clinical Trial Services is closed Monday, May 31, 2010, for the Memorial Day holiday. We will resume regular business hours on Tuesday, June 1. If you have questions or need to coordinate shipments in advance, please don't hesitate to contact your Clinical Trial Project Manager at 800-693-4906. Karl Buer Manager, Sales and Operations Kbuer@biologicstoday.com Ext. 4991 DATE: May 27, 2010 SUBJECT: RTOG 0834 (CANTON Trial), Pre-Randomization Guidelines Attention Investigators With Potential Patients for RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1, "Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma: The CATON Intergroup Trial:" To aid you in the pre-randomization enrollment process, the RTOG has prepared the following guidelines: Patients must be randomized within 6 weeks following surgery. Step 1 registration to initiate the tissue screening process should begin approximately 2 weeks post surgery, to allow sufficient time for the tissue screening process to be complete. The tissue screening process is generally expected to take between 13 and 16 days. If the patient is known to be 1p/19q co-deleted, please consider enrolling the patient in the trial's counterpart for 1p/19q co-deleted tumors, NCCTG N0577 (RTOG 1071); enrollment for RTOG sites is available via the CTSU. Please refer to the attached trial schema, extracted from the CATNON protocol, for additional schematic details. - Schema for CATNON Trial.pdf DATE: December 11, 2009 SUBJECT: Amended and Updated: RTOG 0834 Group-Specific Appendix for United States Sites Amended and Updated: RTOG 0834 Group-Specific Appendix for United States Sites RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma: The CATNON Intergroup Trial Amendment 1: As mandated by CTEP, the CTCAE version was revised from v. 3.0 to the CTEP Active Version of CTCAE. Additional appendix sections were updated to current standard or corrected for clarity and accuracy. Update: Procedures for specimen submission and certification for neurocognitive testing were updated. United States RTOG sites can download a copy of the summary of changes for the amendment and update as well as the amended, updated Group-Specific Appendix by accessing the CTSU website at - https://www.ctsu.org/ and going to the CTSU members' site (requires CTSU user name and password). Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@phila.acr.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at - https://www.rtog.org/; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: November 23, 2009 SUBJECT:RTOG 9813, 0436, 0521, 0525, 0617 & 0834 PROTOCOL NOTICE: Thanksgiving Holiday Shipping Schedule for all study drug products provided through Biologics Biologics Clinical Trial Services is closed for Thanksgiving on Thursday, Nov.26, and Friday, Nov. 27, 2009. They will resume regular business hours on Monday, Nov. 30. If you have questions or need to coordinate shipments in advance, please don't hesitate to contact Karl Buer, the RTOG Clinical Trial Project Manager at 800-693-4906 Ext. 4991 or Kbuer@biologicstoday.com. The study drug products distributed by Biologics include the following: Temozolomide for RTOG 9813, 0525 & 0834 Cetuximab and Paclitaxel for RTOG 0436 & 0617 Taxotere for RTOG 0521 DATE: September 9, 2009 SUBJECT: October RTOG Newsletter Attached is the latest version of the RTOG Newsletter. Highlights include: Updates on RTOG Members & Staff Opening of the New Core Lab ASTRO Presentations List New Study Summaries Spinal Metastasis - RTOG 0631 Radiosurgery & SBRT Brain - RTOG 0825 Bevacizumab for GBM Brain - RTOG 0834 Adjuvant Chemo for Anaplastic Glioma Brain - RTOG 0539 Meningioma Lung - RTOG 0915 SBRT for Inoperable Stage I NSCLC Lung - RTOG 0813 SBRT for Early Stage NSCLC Patient Advocate Article 2009 Publications - RTOG_NL_September2009.pdf DATE: September 1, 2009 SUBJECT: RTOG 0436, 0521, 0525, 0617, 0619 & 0834 Protocol Notice: Holiday Hours for Drug Distributor Biologics Biologics Clinical Trial Services will be closed for the Labor Day holiday on Monday, Sept. 7, 2009. We will resume regular business hours on Tuesday, Sept. 8. If you have questions or need to coordinate shipments in advance, please don't hesitate to contact your Clinical Trial Project Manager at 800-693-4906. RTOG Clinical Trail Manager for RTOG Studies: Karl Buer Kbuer@biologicstoday.com Ext. 4991 DATE: July 22, 2009 SUBJECT: RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1, Activated Activated RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma: The CATNON Intergroup Trial Special Study Notes: EORTC is the lead group for this study, and RTOG is acting as the lead group in North America. United States RTOG sites can download a copy of the protocol, Group-Specific Appendix for United States Sites, and forms for IRB review by accessing the CTSU website at https://www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). All Canadian sites will enroll through NCIC CTG via NCIC CTG procedures. Credit/Funding Notes: The study is approved for 1.0 treatment credits. Sites with patients participating in the quality of life/neurocognitive function component will receive 0.5 DCP cancer control credits (for 88 patients/arm) per eligible patient registered. Sites will receive an additional $2000 per eligible patient registered, for a total of $4000 per patient. 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@acr-arrs.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