0529 Broadcast DATE: March 21, 2008 SUBJECT: RTOG 0529, Closure Closure RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal," will close to patient accrual at 5 PM EST today, because the study has met its accrual objective. Notice of this closure was previously broadcast on March 7, 2008 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/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: March 7, 2008 SUBJECT: RTOG 0529, Closure Closure RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal," will close to patient accrual at 5 PM EST on March 21, 2008, because the study has met its accrual objective. 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/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: February 13, 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: 0522 T1 Radiotherapy Form 0529 T1 Radiotherapy Form 0534 T1 Radiotherapy Form 0615 T1 Radiotherapy Form 0617 T1 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.html For technical support with web data submission, please email websupport@phila.acr.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 11, 2007 SUBJECT: RTOG 0529, Amended: Dose Modifications Adjusted Amended RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal," Amendment 2: Section 7.4 was modified to clarify existing dose modifications for grade 4 diarrhea, grade 3 and 4 mucositis/stomatitis, and grade 3 ANC/platelet toxicity; and (2) to add dose modifications for grade 4 ANC/platelet toxicity. In Appendix I, the description for low white blood cell count was corrected and a description for low platelet count was added. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0529/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/protocols/0529/0529.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. 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/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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 25, 2007 SUBJECT: RTOG 0529 - T1 Available for Web Data Entry Web-Based Electronic Data Submission is now available for the following form: RTOG 0529 – T1 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 Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 11, 2007 SUBJECT: Form Revision Notice - RTOG 0529 FORM REVISION RTOG 0529 Phase II Anal Canal 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=0529/0529tf.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     9-11-07   Changes Made: Element numbers (for internal use) updated in preparation for web data collection of this form. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after 9/25/07 will be returned to the site for transcription Please notify your joint center institutions and affiliates who are not on e-mail. Debora Grant, RN, MSN RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 20, 2007 SUBJECT: New Forms Available for Web-Based Electronic Data Submission WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: Web-Based Electronic Data Submission is now available for the following forms: RTOG 0418 - I1 & TF Forms RTOG 0513 - I1 Form RTOG 0529 - I1 & F2 Forms RTOG 0611 - I1 & F1 Forms 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 14, 2007 SUBJECT: RTOG 0529, Amended and Updated Amended and Updated RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal" Amendment 1: Changes were made to clarify that chemotherapy begins on calendar day 29; serum, plasma, buffy coat, and urine collection was added. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0529/summary_changes.html. Update: Options for nodal status were added to the Eligibility Checklist. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0529/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/protocols/0529/0529.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 editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. IRB review of an update is not required; however, these changes 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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 7, 2007 SUBJECT: Form Revision Notice - RTOG 0529 FORM REVISION RTOG 0529 Phase II IMRT Anal Canal 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=0529/0529i1.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 ;   I1a     6-07-07   Changes Made: Question #6 includes “Colonoscopy”. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after June 15, 2007 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Deb Grant, RN RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 25, 2007 SUBJECT: Web-Based Data Collection Web-Based Data Collection As of Monday, May 14th, for all applicable RTOG study forms (i.e., all forms available for web-entry), centers enrolling patients through RTOG were required to submit RTOG study data via web-entry, rather than on paper forms. This requirement was implemented in order to increase the efficiency and effectiveness of data processing at RTOG Headquarters and at all enrolling centers. We appreciate everyone’s cooperation with this change and are committed to continuous improvement of data management processes and procedures. FORMS AVAILABLE FOR ELECTRONIC DATA SUBMISSION (Centers enrolling patients through RTOG are required to submit RTOG study data via web-entry for the following studies/forms.) 0113 Esophagus Follow-up (F1) 0114 Gastric Follow-up (F1) 0126 Prostate Follow-up (F1) 0128 Cervix - Follow up 0129 Head and Neck Follow-up (F1) 0246 Esophagus Follow-up (F1) 0247 Rectal Follow-up (F1) 0319 Breast Follow-up (F1) 0320 Phase III Brain Follow-up (F1) 0417 Cervix Follow-up (F1) 0418 IMRT Follow-up (F1) 0424 Phase II Brain Follow-up (F1) 0438 Phase I Liver Follow-up (F1) 0522 Advanced H & N Follow-up (F1) 0525 Brain GBM all forms 0529 Phase II Anal Canal Follow-up (F1) 9910 Prostate Follow-up (F1) 9811 Anal Canal Follow-up (F1) 9804 DCIS Breast Follow-up (F1) 9704 Pancreas Follow-up (F1) 9601 Prostate Follow-up (F1) 9413 Prostate Follow-up (F1) 9408 Prostate Follow-up (F1) 9406 Prostate Follow-up (F1) For technical support, please email websupport@phila.acr.org DATE: February 20, 2007 SUBJECT: Form Revision Notice - RTOG 0529 FORM REVISION RTOG 0529 Phase II Anal Canal 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=0529/0529f2.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F2 Post-Treatment Response Form    F2a     2-20-07   Changes Made: Additional question added re: Biopsy information. Discard obsolete versions and commence use of the revised edition immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz and Deb Grant RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 25, 2006 SUBJECT: RTOG 0529 Chemotherapy Dose Administration Clarification Updated RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal" Update: In Section 7.2.1/second paragraph/second sentence, 1.5 mg/3 ml was corrected to 1.5 mg/ 3 ml. Please see the complete summary of changes at: http://www.rtog.org/members/protocols/0529/summary_changes.html The updated protocol can be accessed at: http://www.rtog.org/members/protocols/0529/0529.pdf NOTE: An update is an editorial/administrative change to a protocol. NCI requires that these changes be documented on the protocol title page as "Update Date," not as an amendment. IRB review 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/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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 21, 2006 SUBJECT: RTOG 0529, Activated Activated RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal". You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0529/0529.pdf Forms for this study are available on the RTOG web site at http://www.rtog.org/members/forms/0529/main.html Online (versus Dial-in) registration is mandatory for this study. See the link below for web registration information and instructions. NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; therefore, the version date and activation date 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/0529/summary_changes.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://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html