0438 Broadcast DATE: February 11, 2008 SUBJECT: Form Revision Notice - RTOG 0438 FORM REVISION RTOG 0438 Phase I Liver 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=0438/0438f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1b Followup Form    F1c     2-7-08   Change Made: Q#6 The wording of the question has been revised. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after February 21, 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 RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 14, 2007 SUBJECT: RTOG 0438, Re-Opened to Accrual Re-Opened to Accrual RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases," has been re-opened to accrual effective immediately. Dose level II (40 Gy) was evaluated, and no dose-limiting toxicities occurred at this dose; therefore, the dose has been escalated to dose level III (45 Gy). 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 12, 2007 SUBJECT: RTOG 0438, Temporary Closure Temporarily Closed RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases," is temporarily closed effective immediately for protocol-specified toxicity evaluation. 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: August 27, 2007 SUBJECT: RTOG 0438, Amended and Updated Amended and Updated RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases" Amendment 2: Changes were made to the cover page and sections 3, 5, 6, 9, 10 and 12. Update: A correction was made to the eligibility checklist. Please see the complete summary of changes for the amendment and update at http://www.rtog.org/members/protocols/0438/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/0438/0438.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: 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: June 20, 2006 SUBJECT: RTOG 0438 Amended Amended RTOG 0438, “A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases," Amendment #1. Please see the complete summary of changes at: http://www.rtog.org/members/protocols/0438/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/0438/0438.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/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org Web registration is available 24/7. Information and instructions available at: https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 2, 2006 SUBJECT: Dosimetry Transmittal Form for RTOG 0321, 0418, 0438, 0521and 0522 The Dosimetry Transmittal Form has been added and is available from the RTOG website for the following protocols: RTOG 0321 " A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiotherapy for Adenocarcinoma of the Prostate" RTOG 0418 " A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma" RTOG 0438 " A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases" 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" The Dosimetry Transmittal Form has been revised and is available on the RTOG website for the following protocol: RTOG 0522 "A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed By Surgery For Selected Patients] For Stage III and IV Head and Neck Carcinomas Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Lorraine Quarles, RT(T) RT Quality Assurance American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 215-574-3181 DATE: March 29, 2006 SUBJECT: Forms Revision Notice - RTOG 0438 FORMS REVISION RTOG # 0438 Phase I RT Unresectable Liver Mets The following form for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0438/0438f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1a Follow-up Form F1b   3-29-06   Changes Made: Question #3: Additional information added to choices 3, 4, 5 and 6. Question #7: "Within irradiated fields" added to choices 1 and 2. Question #10: "None" removed from the code table. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 4-7-06 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 available at: https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 17, 2006 SUBJECT: Forms Revision Notice - RTOG 0438 RTOG 0438 FORMS REVISION Phase I: RT Unresectable Liver 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=0438/0438f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1 Follow-Up Form F1a   1-17-06   Changes Made: Questions #11, 12 and 13 added to form for collection of additional information Question #8 (primary tumor status) removed. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after 1-27-06 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 available at: https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 10, 2006 SUBJECT: RTOG 0438 Update Updated RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases." Please see the complete Summary of Changes at: http://www.rtog.org/members/protocols/0438/summary_changes.html NOTE: This update is an editorial/administrative change to the Protocol. NCI requires that this change be documented on the Protocol title page as "Update Date", not as a revision. IRB review is not required; however, this change must be reported to site IRBs. The updated Protocol can be accessed on the RTOG website at: http://www.rtog.org/members/protocols/0438/0438.pdf 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 David Corrie at dcorrie@phila.acr.org. Web registration is available 24/7. Information and instructions available at: https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 03, 2005 SUBJECT: RTOG 0438 Activated Activated RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases" You may download a copy of the protocol for IRB review by accessing the RTOG web site at: http://www.rtog.org/members/protocols/0438/0438.pdf Forms for this study are available on the RTOG web site at: http://www.rtog.org/members/forms/0438/main.html On-line (versus Dial-in) registration is mandatory for this study. See the link below for web registration information and instructions. 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 minor administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes, which can be accessed at:http://www.rtog.org/members/protocols/0438/summary_changes.html 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. 4198, 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 David Corrie at dcorrie@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html