0539 Broadcast DATE: August 31, 2010 SUBJECT: Form Revision Notice - RTOG 0539 PHASE II TRIAL OF OBSERVATION FOR LOW-RISK MENINGIOMAS AND OF RADIOTHERAPY FOR INTERMEDIATE AND HIGH-RISK MENINGIOMAS Form Revision The following forms(s) 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=0825/0825SR.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date SR Radiology Review Form SRb - 8/26/10 Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 9/8/2010 will be returned to the site for transcription. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. A complete listing of all forms available for web-entry is available at: http://www.rtog.org/members/webreg.html For technical support with web data submission, please e-mail websupport@acr-arrs.org Please notify your joint center institutions and affiliates who are not on e-mail. DATE: August 26, 2010 SUBJECT: RTOG 0539 August 2010 Newsletter Attached is the August issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Technologic Advances in the Treatment of Meningiomas Enrollment - 0539 August Newsletter.pdf DATE: July 8, 2010 SUBJECT: RTOG 0539 June/July 2010 Newsletter Attached is the June/July issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Thoughts From the Chair: New Light on Atypical Meningiomas Amendment 1 Recap Enrollment - - 0539 June_July Newsletter.pdf DATE: July 1, 2010 SUBJECT: RTOG 0539, Amended and Updated Amended and Updated RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Amendment 1: Use of protons was added; other clarifications and corrections were made throughout. Update: Sub-section numbering was corrected in various places. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0539/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0539/0539.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 of the amendment 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. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Sites must submit IRB approval for the amendment to CTSU. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: May 28, 2010 SUBJECT: RTOG 0539 May 2010 Newsletter Attached is the May issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Comments From the Chair: Central Radiology Review Form Enrollment Kathryn Okrent Protocol Associate, Brain Trials Radiation Therapy Oncology Group Tel: 215-717-0856 Fax: 215-940-8809 kokrent@acr-arrs.org - 0539 May 2010 Newsletter.pdf DATE: April 23, 2010 SUBJECT: RTOG 0539 April 2010 Newsletter Attached is the April issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Central Pathology Review Observations MRI for Radiation Planning Submission of Surgical Pathology and Surgical Operative Reports Enrollment - 0539 April 2010 Newsletter.pdf DATE: March 31, 2010 SUBJECT: RTOG 0539 March 2010 Newsletter Attached is the March issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Thoughts From the Chair Central Pathology Review Form Clarification Surgical Operative Reports Reminder Enrollment Information - 0539 March Newsletter.pdf DATE: March 17, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0539 RTOG 0539 PHASE II TRIAL OF OBSERVATION FOR LOW-RISK MENINGIOMAS AND OF RADIOTHERAPY FOR INTERMEDIATE AND HIGH-RISK MENINGIOMAS Web-Based Electronic Data Submission is now available for the following form: F1 Follow-up 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 March 26, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Barbara Kaiser, RN RTOG Data Management DATE: February 25, 2010 SUBJECT: RTOG 0539 February 2010 Newsletter Attached is the February issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Thoughts From the Chair Allowance for Target Dose Increase Enrollment Information - 0539 February 2010 Newsletter.pdf DATE: January 28, 2010 SUBJECT: RTOG 0539 January Newsletter Attached is the January issue of the newsletter for RTOG 0539, “Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas.” Highlights include: Kick-off breakfast thank you Recruitment material reminder Special thank you to Arizona Oncology Services Foundation Enrollment information 0539 January 2010 Newsletter.pdf DATE: January 8, 2010 SUBJECT: Reminder: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Reminder: Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas IMPORTANT: The discussion will take place in Grand Salon E, not the Florida Foyer as published in the final agenda to be distributed at the RTOG Meeting. Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Grand Salon E, Tampa Marriott Waterside Hotel - RTOG 0539 Invitation.pdf DATE: January 7, 2010 SUBJECT: room change: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Please note the room change for this discussion. Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Grand Salon E, Tampa Marriott Waterside Hotel DATE: January 6, 2010 SUBJECT: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Florida Foyer, Tampa Marriott Waterside Hotel - RTOG 0539 Invitation.pdf DATE: December 17, 2009 SUBJECT: RTOG 0539 December Newsletter Attached is the December issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include information on: Recruitment Material Tampa Kick-Off Breakfast Enrollment - 0539 December Newsletter.pdf DATE: November 18, 2009 SUBJECT: RTOG 0539 November Newsletter Attached is the November issue of the newsletter for RTOG 0539, “Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas.” Highlights include: Important Pathology Reminder Information on Recruitment Material & Study Kick-Off Event Enrollment Attachment DATE: November 6, 2009 SUBJECT: RTOG 0539, Pathology Reminder RTOG 0539, Pathology Reminder When submitting tissue for Central Pathology Review in conjunction with Step 1 Registration, please remember to send one H&E slide per paraffin block, rather than one representative H&E slide. This can be accomplished most efficiently and expeditiously by simply requesting that the histology lab cut 2 sets of slides up front (one for routine diagnosis and the other for central review). Please refer to Section 10.2 of the protocol for Central Pathology Review submission details. Contact Dr. Arie Perry with questions (aperry@wustl.edu; 314-362-7426). DATE: October 19, 2009 SUBJECT: RTOG 0539 October Newsletter Attached is the first edition of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Study Summary ARRA Funding/Case Payment Pathology Reminder Information on Recruitment Material Enrollment - 0539 October Newsletter.pdf DATE: October 13, 2009 SUBJECT: RTOG 0539, Enhanced Case Payment Announcement Announcement of Enhanced Case Payment RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" RTOG is pleased to announce that sites accruing to RTOG 0539 will receive an additional $3700 per eligible patient registered, for a total of $5700 per patient. This supplemental funding is made possible by funds received through CTEP's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program, under the 2009 American Recovery and Reinvestment Act (ARRA) economic stimulus plan. CTEP designed the ACTNOW program to provide supplemental funds for select novel oncology trials that have the potential to complete accrual within 2 years. CTEP formally selected RTOG 0539 as an ACTNOW recipient in May 2009. DATE: September 29, 2009 SUBJECT: Web Data Submission Update - RTOG 0539 ATTENTION - ALL 0539 PARTICIPANTS!! Effective immediately the 0539 I1 form is available for remote web data entry. All forms submitted on paper after October 2, 2009 will be returned. Thank you, Barbara Kaiser R.N. RTOG Data Management 215-574-3221 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: July 24, 2009 SUBJECT: Form Revision Notice - RTOG 0539 RTOG 0539 Phase II Feasibility of IMRT for intermediate and High Risk Meningiomas and Observation for Low Risk Meningiomas Forms Revision 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=0539/0539I1.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     7-24-09   Changes Made: Schema numbers corrected to allow specify for question #6 "prior other type of treatment". Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after 8/2/2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Contact Barbara Kaiser R.N., RTOG Data Management @ 215-574-3221 with questions DATE: June 19, 2009 SUBJECT: RTOG 0539, Activated Activated RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0539/0539.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0539/main.html Special Study Notes: This study was selected by CTEP as a novel oncology trial for special support under the 2009 American Recovery and Reinvestment Act (ARRA) economic stimulus plan. Sites enrolling patients on RTOG 0539 will receive enhanced case payment, to be administered under CTEP's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program. CTEP designed the ACTNOW program to provide supplemental funds for select oncology trials that have the potential to complete accrual within 2 years. When RTOG and CTEP have finalized the terms of this funding, RTOG will send a broadcast to sites to describe the supplemental payment details. Regulatory Notes: NCI policy requires that the "Version Date" of the protocol title page reflect the date that the protocol was submitted by RTOG to NCI. 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/0539/summary_changes.html 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, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. 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.