Member Update FUTURE MEETINGS: June 19-22, 2008 at Loews Philadelphia Hotel, Philadelphia, Pennsylvania January 15-18, 2009 at Sheraton New Orleans Hotel, New Orleans, Louisiana June 25-28, 2009 at Chicago Marriott Downtown, Miracle Mile, Chicago, Illinois January 14-17, 2010 at Tampa Marriott Waterside, Tampa, FL June 17-20, 2010 at Loews Philadelphia Hotel, Philadelphia, PA DATE: May 9, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. Cetuximab Investigator Notification ImClone MFR # 08-02-14293 5-7-08.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.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 DATE: May 9, 2008 SUBJECT: RTOG 0521 & 0525 Protocol Notice: Important Information About Drug Shipments Biologics, the distributor providing study agent for RTOG 0521 & 0525 will be closed and not processing drug orders Friday, May 23 through Monday, May 26, 2008. Please plan accordingly 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" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" The company is relocating to a larger facility. Company telephone, fax numbers and email addresses will remain unchanged. Normal business will resume on Tuesday, May 27th. DATE: May 8, 2008 SUBJECT: RTOG 0525, Closure Closure RTOG 0525, "Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma," will close to patient accrual at 5 PM EST June 13, 2008, because it is anticipated to have met its accrual objective by that time. Please notify your affiliates who 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.orgby 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Erbitux-IB12-ESR 274 2.pdf - Erbitux-IB12-ESR275.pdf - Erbitux-IB12-ESR 276.pdf - Erbitux-IB12-ESR268-Initial_Periodic fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab 1536472 RTOG-0625 FU 1.pdf - Bevacizumab and Cetuximab 1199283 S0536 - FU 1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates who 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.orgby 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP006508 FU1.pdf - 2008SP006508 initial.pdf - 2008SP000756 F-U2.pdf - 2008SP001606 initial.pdf - 2008SP001728 FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB During a recent audit of Broadcast RTOG Safety Reports, it was discovered that the following F/U Safety Report for Cetuximab was not distributed: RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - SU-167 1.pdf - SU-167 1 - Medwatch 05-02-06178-5 f-up-2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB During a recent audit of broadcast RTOG Safety Reports, it was discovered that the following Safety Reports for Bevacizumab, which were previously broadcast on 2/8/07, may not have been received by all participating sites. Please disregard any duplicate reports. RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note although these are both follow-up Reports, they contain all the information in the initial reports, which were not originally provided by CTEP. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab-Investigator Notification-Genentech-Mfr.Rpt. 230653-January-29-2007.pdf - Bevacizumab-Investigator Notification-Genentech-Mfr Rpt 233053-January-29-2007.pdf 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.orgby 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE During a recent audit of broadcast RTOG Safety Reports, it was discovered that the following Safety Reports for Temozolomide, which were previously broadcast on 2/7/07 and 3/15/07, may not have been received by all participating sites. Please disregard any duplicate reports. RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 22Jan2007_2006SP008904_analysis.doc - 22Jan2007_2006SP008904_Medwatch.pdf - 23Jan2007_2006SP004547_analysisfu1.doc - 23Jan2007_2006SP004547_MedWatch_FU1.pdf - 24Jan2007_2007SP001239_analysis.doc - 24Jan2007_2007SP001239_Medwatch.pdf - 26Jan2007_2007SP000310_analysis.doc - 26Jan2007_2007SP000310_Medwatch.pdf - 26Jan2007_2006SP008904_analysisfu2.doc - 26Jan2007_2006SP008904_MedWatch_FU2.pdf - 31Jan2007_2006SP004547_analysisfu2.doc - 31Jan2007_2006SP004547_MedWatch_FU2.pdf - 12Mar2007_2007SP003140_analysisfu2.doc - 12Mar2007_2007SP003140_MedWatch_FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 29, 2008 SUBJECT: Erbitux Warehouse Closure Reminder - Memorial Day *******PLEASE NOTE******* The BMS Distribution Center will be closed for shipments on Monday 26-May-2008 for Memorial Day. The last shipment date will be Thursday, 22-May-2008. The office will resume work on Tuesday, 27-May-2008. *********************************************************************************************************** For your convenience, below is the BMS Distribution Center Warehouse Closure Dates for 2008. Please plan accordingly. Warehouse Closure Dates: 2008 Last Shipment Date Monday, May 26th: Memorial Day Thursday, 22-May-2008 Friday, July 4th Independence Day Wednesday, 2-July-2008 Monday, September 1st: Labor Day Thursday, 28-August-2008 Thursday, November 27th Friday, November 28th Thanksgiving Tuesday 25-November-2008 December 24th through January 2nd, 2009 Wednesday, 18-December-2008 DATE: April 29, 2008 SUBJECT: RTOG 0822, Activated Activated RTOG 0822, "A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0822/0822.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0822/main.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, 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. DATE: April 29, 2008 SUBJECT: RTOG 0615, Amended Amended RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer", Amendment 3: The radiation dose to the high risk subclinical region was amended; at NCI's request, information indicating that the bevacizumab supplied for the study is intended for clinical use only was deleted. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0615/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/0615/0615.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 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 are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 29, 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: 0415 T1 Radiotherapy Form 0618 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.html 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 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. DATE: April 24, 2008 SUBJECT: RTOG 0518, Amended Amended RTOG 0518, "A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer," Amendment 4: Study arm 2 was changed from placebo and standard treatment to standard treatment alone. In addition, frequency of treatment was reduced to decrease risk from potential zoledronic acid toxicities. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0518/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/0518/0518.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 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 are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 24, 2008 SUBJECT: RTOG 0436, Pre-Activation Notification Pre-Activation Notification RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery," was approved by the NCI on April 17, 2008. RTOG will activate this study (open it for patient enrollment) on June 30, 2008. RTOG will broadcast on that date to notify institutions that the study is open to accrual. The study is approved for 1.0 CTEP treatment credits and 0.5 DCP cancer control credits. Important: Investigators should complete the pre-registration requirements for 3D-CRT (see Section 5.1 of the protocol) and should forward the protocol and forms to their site IRBs for review before June 30. Institutions can access a copy of the NCI-approved protocol for IRB review on the RTOG website at http://www.rtog.org/members/protocols/0436/0436.pdf The protocol summary, a one-page overview of the study, is located on the RTOG website at http://www.rtog.org/summaries/gi.html The case report forms are available on the RTOG website at http://www.rtog.org/members/forms/0436/main.html Please note that the study is NOT YET OPEN TO ACCRUAL- but investigators should complete pre-registration requirements and seek their site IRB's approval for the study prior to activation. Please notify your affiliates who are not on e-mail DATE: April 22, 2008 SUBJECT: Forms Revision RTOG Study # 0126 Study Title Phase III study of high dose 3D-CRT/IMRT versus standard dose 3D-CRT/IMRT for localized prostate cancer Forms Revision The following form(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=0126 The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1    I1c     4/22/2008   Change- Internal changes Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after May 5, 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,RN , RTOG Data Management Please note that effective April 15, 2004 RTOG no longer mails a forms packet on new registrations. Forms for all open studies and many of our closed studies are available on the RTOG web site. If the form you need is not available on our web site, you may request one by calling 215-574-3191 or you may fax your request to 215-574-0300. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html 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 DATE: April 21, 2008 SUBJECT: RTOG 0514, Amended Amended RTOG 0514, "Establishment of a Head and Neck Cancer Tissue/Specimen Repository", Amendment 4: Sites submitting the required fresh, flash frozen specimens will now receive 1.0 case credit in addition to the per-case reimbursement; Section 1.3 was amended to clarify that the majority of patients are expected to be subsequently enrolled on an active RTOG study. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0514/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/0514/0514.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 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 are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 18, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Erbitux-IB12-ESR273.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 18, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab1230483RTOG-0625-ISRFU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 17, 2008 SUBJECT: Web-Based Electronic Data Submission Update WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: Web-Based Electronic Data Submission is now available for the following form(s): 0526 FI 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 http://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 15, 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: 0630 T1 Radiotherapy Form 0621 TI Radiotherapy Form 0521 T1 Radiotherapy Form 0418 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 are at http://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 15, 2008 SUBJECT: RTOG 9406, Amended Amended RTOG 9406, "A Phase I/II Dose Escalation Study Using Three Dimensional Conformal Radiation Therapy for Adenocarcinoma Of The Prostate" (a closed study), Amendment 18: Buffy coat cell collection and banking for Single Nucleotide Polymorphisms (SNPs) analysis at patient follow-up visits has been added. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/94-06/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/94-06/94-06.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, 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 DATE: April 11, 2008 SUBJECT: RTOG 0247 Protocol Notice: OXALIPLATIN IND-SAFETY REPORT [PASSWORD] *** Please note there is an error on the CIOMS Forms that list the attached Safety Reports as follow-ups. It has been confirmed with Sanofi-Aventis Canada that the attached reports are Initial Reports. Please make a note of this. Thanks. The password for the Oxaliplatin IND Safety Report that was broadcast on 4/11/08 is included below: Password: Picasso1 Please note that this password is case sensitive, so please type exactly as noted above. 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG 0247 Protocol Notice: OXALIPLATIN IND-SAFETY REPORT [PASSWORD] The password for the Oxaliplatin IND Safety Report that was broadcast on 4/11/08 is included below: Password: Picasso1 Please note that this password is case sensitive, so please type exactly as noted above. 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2008SP000756 F-U1.pdf - 2007SP018230 FU5.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab Investigator Notification Genentech MFR 254163 04-04-2008.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB CETUXIMAB *** Please note there is an error on the CARES Form that lists the attached Safety report as a Expedited Safety Report #2. It has been confirmed with BMS that this is an Initial Report. Please make a note of this. Thanks. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - dasatinib-ib07-esr02.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Cetuximab - Investigator Notification - Imclone Rpt 05-02-05850 - 03-31-2008.pdf - Cetuximab - Investigator Notification - Imclone Rpt 08-02-13981 - 03-31-2008.pdf - Erbitux-IB12-ESR265-fu01.pdf - Cetuximab - Investigator Notification - Imclone MFR 07-02-13171.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 9, 2008 SUBJECT: RTOG 0225: For sites that will receive hardcopy forms revision notice Form Revision Notice: RTOG 0225 Phase II IMRT + Chemo for Nasopharyngeal Forms The following form(s) for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0225/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1a    I1b /     4-8-2008   Change Made: Q16 Added to collect Histology (WHO Scores) This information is needed for study outcome, which is time sensitive. Please look for the hardcopy memo with instructions and submit information promptly. Thank you, Linda Messett RN BSN Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 9, 2008 SUBJECT: RTOG 0417 for Locally Advanced Cervix Cancer Continues to Accrue RTOG 0417, "A Phase II Study of Bevacizumab in Combination With Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients With Locally Advanced Cervical Carcinoma," is OPEN to accrual. Fast Facts The trial passed the planned early toxicity test and re-opened for patient entry in Dec 2007. Bevacizumab is supplied free of charge to patients enrolled on the trial. Radiotherapy is standard. Participation in the OPTIONAL tissue submission and brachytherapy image submission portions of the trial is desired but NOT MANDATORY. Completing accrual to this study in a timely fashion is necessary for the RTOG GYN Working Group to meet its research goals. Please e-mail the study PI, Dr. Schefter (Tracey.Schefter@UCHSC.edu), if there are specific issues that are impeding accrual to this trial at your institution. Thank you in advance for your support of this trial. DATE: April 8, 2008 SUBJECT: RTOG 0621, Activated Activated RTOG 0621, "Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial". Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0621/0621.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0621/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/0621/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 DATE: April 7, 2008 SUBJECT: Forms Revision Notice II-534 RTOG Study # 0534 Phase III trial of short term androgen deprivation plus RT with rising PSA after prostatectomy Forms Revision The following form(s) for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0534/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F0    F0a     04/02/08 F1    F1a     04/02/08   Change Made: Q#10 and both forms updated to reflect the correct code numbers for the unit of measure for the testosterone laboratory results. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after May 1, 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, RN, RTOG Data Management Please note that effective April 15, 2004 RTOG no longer mails a forms packet on new registrations. Forms for all open studies and many of our closed studies are available on the RTOG web site. If the form you need is not available on our web site, you may request one by calling 215-574-3191 or you may fax your request to 215-574-0300. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 3, 2008 SUBJECT: RTOG 0232, Amended and Updated Amended and Updated RTOG 0232, "A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma." Amendment #4 changes include: The sample size has been revised. Update includes: The RTOG Biospecimen Resource information was updated. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0232/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/0232/0232.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, 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 DATE: April 3, 2008 SUBJECT: RTOG 0622, Activated Activated RTOG 0622, "A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy." Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0622/0622.pdf. Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0622/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/0622/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 DATE: April 2, 2008 SUBJECT: RTOG 0127/ECOG E5597: Memo and drug telephone line RTOG sites participating in RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer" The following information was received from the ECOG Coordinating Center on April 2: There is a memo now available concerning important information regarding the increased amount of selenium in supplements/multivitamins. RTOG sites can access the memo via a link to ECOG's web site, http://www.ecog.org/rtog/. On ECOG's web site, scroll down to ECOG 5597. In addition: The ECOG Coordinating Center is pleased to announce a new resource for clinical sites to assist with questions regarding drug orders that are processes by the ECOG Drug Team. We have established a Drug Team telephone line, 617-582-7990, that will connect callers directly to a member of the ECOG Drug Team. Staff will be available to take calls during the business hours of 9 A.M. to 5 P.M. Eastern Time, Monday through Friday. Please note that this resource is only available for drug orders that are processed by the ECOG Drug Team. Questions regarding study drugs ordered from the NCI should be directed to the PMB at 301-496-5725. NOTE: RTOG sites must provide the User name: rtog and Password: igprot to access ECOG's documents. 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, 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 DATE: April 2, 2008 SUBJECT: RTOG 0517 Featured in NCI Bulletin – Managing Bone Metastases: Can Radiopharmaceuticals Help? RTOG 0517 is featured in the current edition of the NCI Bulletin in an article entitled, Managing Bone Metastases: Can Radiopharmaceuticals Help? Attached is a reprint of the article. - RTOG_0517_NCI_Cancer_Bulletin_040108.pdf The entire Bulletin can be found at: http://www.cancer.gov/NCICancerBulletin/NCI_Cancer_Bulletin_040108 DATE: March 31, 2008 SUBJECT: RTOG SEMI-ANNUAL MEETING-JUNE 19-22, 2008 The RTOG Semi-Annual Meeting will take place from June 19-22, 2008 at the Loews Philadelphia Hotel in Philadelphia, Pennsylvania. We are planning an all attendee reception to celebrate RTOG's 40th year on Friday, June 20, 2008. The symposium is scheduled on Friday, June 20 from 9am to 1pm and the topic is Proton Therapy in a Cooperative Group Setting. The meeting brochure is available at: http://www.rtog.org/meeting/brochure.pdf On line registration for the meeting is available at: https://registrations.acr.org/rtog/Reg.aspx Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 31, 2008 SUBJECT: RTOG 0615, Re-Opened Re-Opened RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer", has been re-opened to patient accrual, effective immediately. The protocol-specified interim analysis of adverse events evaluating the rate of hemorrhages reported has been completed. Only one grade 1 hemorrhage was reported (urogenital), and it was unlikely due to protocol treatment. 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, 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 DATE: March 28, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" RTOG 0227 "PHASE I/II STUDY OF PRE-IRRADIATION CHEMOTHERAPY WITH METHOTREXATE, RITUXIMAB, AND TEMOZOLOMIDE AND POST-IRRADIATION TEMOZOLOMIDE FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA" RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 2007SP007552 FU8.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 28, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB *** Please note there is an error on the MEDWATCH Form that lists the attached Safety report as a Follow-Up #3. It has been confirmed with ImClone and BMS that this is a Folllow-Up#2. Please make a note of this. Thanks. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC) " RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Erbitux-IB12-ESR163-FU02 MEDWATCH ERROR not FU3.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html 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 DATE: March 28, 2008 SUBJECT: RTOG 0424, Closure Closure RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," will close to patient accrual at 5 PM EST today, because the study has met its accrual objective. The possibility of amending the study to increase the sample size is under discussion. When a final decision is made, a broadcast will be sent. Notice of this closure was previously broadcast on 3/14/08. 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 DATE: March 27, 2008 SUBJECT: RTOG 0630, Updated Updated RTOG 0630, "A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity": Update: Section 12.2, IGRT Submission, was updated. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0630/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/0630/0630.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; for clarity, the broadcast date of the update is provided in parentheses. 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. 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 DATE: March 25, 2008 SUBJECT: CALGB 30610/RTOG 0538: Activated Activated CALGB 30610/RTOG 0538, "Phase III Comparison Of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin And Etoposide" Note: This is a CALGB-coordinated study in which RTOG is participating. RTOG sites can download a copy of the protocol and forms for IRB review by accessing the CTSU web site at http://www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). CALGB-30610 is listed on the right. 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 DATE: March 25, 2008 SUBJECT: RTOG 0630, Activated Activated RTOG 0630, "A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0630/0630.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0630/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/0630/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 DATE: March 25, 2008 SUBJECT: Web-Based Electronic Data Submission Update for RTOG 0526 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: Web-Based Electronic Data Submission is now available for the following form: RTOG 0526 I1 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 24, 2008 SUBJECT: RTOG 0630 Pre Activation Notification Pre Activation Notification RTOG 0630 A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity is scheduled to be activated on March 25, 2008. Image Guided Radiotherapy (IGRT) is mandatory for this study. Each Institution must be credentialed for IGRT (see sect. 5.0 of the protocol) prior to patient registration. Note: IMRT or 3DCRT credentialing is also required. All Credentialing Requirements for RTOG 0630 are available under 'Protocols' on the ATC web site: http://atc.wustl.edu DATE: March 21, 2008 SUBJECT: RTOG (0324), (0234) & 0522 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Erbitux-IB12-ESR272.pdf - Erbitux-IB12-ESR271.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html 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 18, 2008 SUBJECT: Form Revision Notice - RTOG 0617 FORM REVISION RTOG 0617 Phase III NSCLC 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=0617/0617i1.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    I1c     3-17-08   Change Made: Question #9 expanded code table (returned to original version to include five choices) regarding histological type. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after April 1, 2008 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski. RN, BA, CCRP RTOG Research Associate, Lung Team 215-574-3159 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 14, 2008 SUBJECT: RTOG 0424, Closure Closure RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," will close to patient accrual at 5 PM EST on March 28, 2008, because the study has met its accrual objective. The possibility of amending the study to increase the sample size is under discussion. When a final decision is made, a broadcast will be sent. 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 14, 2008 SUBJECT: RTOG 0513, Re-Opened to Accrual Re-Opened to Patient Accrual RTOG 0513, "A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme," has been re-opened to patient accrual. The phase II portion of this study (Arm 4) is now in effect. The maximum tolerated dose (MTD) of motexafin gadolinium from the phase I portion is 5 mg/kg. The protocol will be amended to reflect the MTD. 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