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DATE: July 21, 2010
SUBJECT: RTOG 0614, Closure Notice
Closure Notice
RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy," will close to patient accrual at 5 PM EST, today, Wednesday July 21, because the study has met its accrual objective. (Notice of this closure was broadcast on July 7, 2010.)
Please notify your affiliates that are not on e-mail.
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DATE: July 7, 2010
SUBJECT: RTOG 0614, Closure Notice
Closure Notice
RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy," will close to patient accrual at 5 PM EST, Wednesday July 21, because the study has met its accrual objective.
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 mailto: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 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.
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DATE: May 25, 2010
SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614
RTOG 0614
A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY
Web-Based Electronic Data Submission is now available for the following form:
QL - Medical Outcome Scale: Cognitive
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 e-mail websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.
Forms received in paper format after 06/04/2010 will be returned to the site for web submission.
Please notify your joint center institutions and affiliates who are not on e-mail.
Sandrine Geinoz, PhD, CCRP
RTOG Data Management
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DATE: May 13, 2010
SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614
RTOG 0614
A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF
COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY
Web-Based Electronic Data Submission is now available for the following form:
NP - Neurocognitive Evaluation Summary 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 e-mail websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.
Forms received in paper format after 05/27/2010 will be returned to the site for web submission.
Please notify your joint center institutions and affiliates who are not on e-mail.
Sandrine Geinoz, PhD, CCRP
RTOG Data Management
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DATE: April 19, 2010
SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614
RTOG 0614
A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY
Web-Based Electronic Data Submission is now available for the following form:
PQ - FACT-Br
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 e-mail web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214.
Forms received in paper format after April 30, 2010 will be returned to the site for web submission.
Please notify your joint center institutions and affiliates who are not on e-mail.
Sandrine Geinoz, PhD, CCRP
RTOG Data Management
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DATE: November 6, 2009
SUBJECT: Neurocognitive Assessments for RTOG 0424, 0525, 0534, 0614 and 0825
When completing the neurocognitive assessment on your patients, please submit to Headquarters the summary form only. The summary form contains the scores from the evaluations. You are to keep the worksheets in the patient's record for audit purposes. Any worksheets submitted to Headquarters will be returned to the site.
The current studies utilizing the neurocognitive assessment are:
RTOG#0424
RTOG#0525
RTOG#0534
RTOG#0614
RTOG#0825
Please notify your joint center institutions and affiliates who are not on e-mail.
Roseann Bonanni, CTR, CCRP
RTOG Data Management
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DATE: May 19, 2009
SUBJECT: RTOG 0614 and 0825: New Temporary Web Link for the Neurocognitive Tests
New Temporary Web Link for Neurocognitive Tests - RTOG 0614 and 0825
MD Anderson Cancer Center has changed its entire web site and the web page for the training video of neurocognitive tests has been relocated temporarily. The new link is available in the "Neurocognitive Training Procedure Letter" posted along with neurocognitive tests on the RTOG website.
When a new permanent web site is established, the definitive link for neurocognitive tests will be broadcast.
Thank you for sharing this email with your affiliate institutions that are not included in the mailing distribution list.
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DATE: May 11, 2009
SUBJECT: RTOG 0614: Neurocognitive and Quality of Life Assessments
RTOG 0614 Neurocognitive and Quality of Life Assessments
Per statistical guidelines and to satisfy the protocol endpoints, MS, NP, PQ and QL forms need to be submitted for each specific time point as outlined in section 12.0 of the protocol.
If protocol treatment is discontinued before completion, neurocognitive and quality of life assessments still must be done if the patient is willing to participate.
The cover sheet for each time point must be submitted regardless of whether the form was completed. Please indicate the time point missed and submit the cover sheet of the corresponding form indicating the reason why the test was not done.
Thank you for your assistance in this matter.
Sandrine Geinoz, PhD, CCRP
RTOG Research Associate
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: May 11, 2009
SUBJECT: RTOG 0614 & 0825 Neurocognitive Assessment Forms - Trail Making Tests
RTOG 0614 & 0825 - Trail Making Test Data Sheets
Please Note: The trail making test data sheets for both of the above studies have been corrected. The instructions for the Trail Making Test Part B, Question 3(highlighted) have been corrected to read 5 minutes instead of 3 minutes (see below)and the corrected version has been posted on the RTOG web site.
Trail Making Test Part B:
1. Did the patient do Sample B before attempting Part B? ☐ Yes ☐ No
2. Total amount of time the patient was tested: ____ : ____ ____(min:sec)
3. Did the patient reach the "END" of the test?
☐Yes
☐ No, tested for 5 minutes OR ☐ No, tested for <5 minutes
If No, specify the last number/letter reached on the test: ____
Please notify your joint center institutions and affiliates who are not on e-mail.
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DATE: March 20, 2009
SUBJECT: RTOG 0614 - Guidelines for Submission of TF Form
RTOG 0614
"A randomized, Phase III, double-blind, placebo-controlled trial of memantine for prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy"
Guidelines for submission of the TF form for RTOG 0614 are now available on the RTOG website at the following address:
http://www.rtog.org/pdf_forms.html?members/forms=0614/TF_Guidelines.doc
If you need further assistance, please contact RTOG Data Management at 215-574-3214.
Please notify your affiliates who 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 rtogbroadcast@acr-arrs.org
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DATE: March 6, 2009
SUBJECT: Form Revision Notice - RTOG 0614
RTOG 0614
Form Revision
Phase III Memantine/Brain Mets
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=0614/0614i1.pdf The edition code for case report forms is found in the lower right corner of the form.
| Form Type | New Version Code/Date |
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| I1 Initial Evaluation Form | I1a 3-6-09 |
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Changes Made: Question #11: Additional element added in code table #5 - total resection.
Web-based data submission is mandatory for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web data submission is available at http://www.rtog.org/members/webreg.html
For technical support with web data submission, please e-mail websupport@acr-arrs.org
Questions regarding information being collected on the forms should be directed to RTOG Data Management at 25-574-3214.
Please notify your joint center institutions and affiliates who are not on e-mail.
Sandrine Geinoz, PhD, CCRP
RTOG Data Management
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: 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@acr-arrs.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@acr-arrs.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@acr-arrs.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@acr-arrs.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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