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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
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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
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DATE: April 29, 2008
SUBJECT: RTOG 0614 Protocol Notice: PQ Form Revised
The FACT-Br tool has been revised and all institutions participating in the Quality of Life assessment must use the new updated version of the PQ form available on the RTOG website.
Please discontinue using the original version, this change is effective immediately.
Revision of the protocol reflecting this change will be made in the next amendment and a broadcast will be sent out to inform all institutions at that time.
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DATE: April 22, 2008
SUBJECT: Web-Based Electronic Data Submission
WEB-BASED ELECTRONIC DATA SUBMISSION
Web-Based Electronic Data Submission is now available for the following RTOG forms:
0614 T1 Radiotherapy Form
0623 TI Radiotherapy 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.htm
For technical support with web data submission, please email websupport@phila.acr.org.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: March 28, 2008
SUBJECT: RTOG 0614, Activated
Activated
RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy"
Institutions can download a copy of the protocol for IRB review by accessing the RTOG Web site at http://www.rtog.org/members/protocols/0614/0614.pdf
Forms for this study also are available on the RTOG Web site at http://www.rtog.org/members/forms/0614/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/0614/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, http://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/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
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