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Date Broadcast
2/8/2016 Subject: NRG Oncology Weekly Broadcast February 8, 2016

CLOSURES AND SUSPENSIONS
HEAD & NECK
RTOG 1216: Temporary Closure Notice dated February 8, 2016; Phase II component met accrual and will close for protocol-specified analyses at 5 PM Monday, February 22.

AMENDMENTS AND UPDATES

HEAD & NECK
RTOG 0234: Amendment 9, Version Date: January 26, 2016
RTOG 0522: Amendment 10, Version Date: January 26, 2016
NRG-HN001: Study Memorandum dated February 8, 2016

FORM UPDATES
RTOG 0815:
F0 and F1 forms have been updated. 

9/8/2014 Subject: NRG Oncology Weekly Broadcast

Publications

NRG Oncology is pleased to report the scientific articles and abstracts that have appeared or have been presented during the previous week. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.

HEAD AND NECK
Ang KK, Zhang Q, Rosenthal DI, Nguyen-Tan PF, Sherman EJ, Weber RS, Galvin JM, Bonner JA, Harris J, El-Naggar AK, Gillison ML, Jordan RC, Konski AA, Thorstad WL, Trotti A, Beitler JJ, Garden AS, Spanos WJ, Yom SS, Axelrod RS. Randomized phase III trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III to IV head and neck carcinoma: RTOG 0522. J Clin Oncol. 2014 Aug 25. pii: JCO.2013.53.5633. [Epub ahead of print] PMID: 25154822. Read more.

Publications Reminders
Please note the following upcoming abstract submission deadline dates:

Upcoming abstract submission deadlines
Gastrointestinal Cancers Symposium (ASCO/ASTRO/SSO/AGA), abstract submission deadline, Sept 16, 2014; late-breaking deadline, Nov 20, 2014, for 2015 meeting in San Francisco. 

SSO abstract submission deadline Sept 26, 2014, for 2015 meeting in Houston.

News

Education/Training:
Vision Tree Webinar - NRG Oncology Research Associates working on RTOG 0938, 0924, and 0920 can find the VTOC Webinar Training Series schedule and registration on the legacy RTOG website under Research Associates – Education/Training. The next session is scheduled for September 10, 2014 at 2 pm ET/ 1 pm CT / Noon MT / 11 am PT. Space is limited so register now and reserve your seat.

Protocol Activity

GYN

GOG-0274/RTOG 1174 September 2014 Outback Newsletter has been posted.

OUTBACK_newsletter__Sep14.pdf

LUNG
RTOG 1306 Action Letter and Amendment 3: 8/27/2014
NRG Oncology has received an Action Letter for crizotinib
Accrual of new patients must be suspended until the IRB of record has reviewed and approved a CTEP-approved amendment created in response to this Action Letter. This amendment can undergo expedited approval at the discretion of the IRB Chair/designee as explained on the first page of the Action Letter.

Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient’s willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements.

OTHER PROTOCOL NOTICES

RTOG 1010 Accrual
The Current Accrual listed on the RTOG Website on the Protocol Information Page for RTOG 1010 reflects the total accrual to STEP 1 (HER2 screening). This study will continue to accrue until 160 cases have completed STEP 2 registration. The current accrual to RTOG 1010 - STEP 2 registration is 147 as of 8/31/2014. Please continue to screen your patients for this very important study and we appreciate all of your efforts.

Meetings

ASTRO Annual Meeting
The ASTRO Annual Meeting takes place Sept 14-17, 2014, in San Francisco, CA.
View NRG Oncology’s scientific presentations at ASTRO.

Visit the ASTRO Annual Meeting page for upcoming scientific meetings.

2/11/2014 9:57:27 AM Subject: RTOG 0522, Amended

Amended
RTOG 0522, “A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas” (a closed study): Amendment 9: As required by CTEP, the Principal Investigator has been changed. Since Dr. Ang is deceased, Dr. Rosenthal, the former Radiation Oncology Co-Chair for the U.S. now will serve as Principal Investigator/Radiation Oncology U.S.

Note: No changes to the sample consent were made in this amendment.

Sites can access the complete summary of changes for this amendment at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=8352                                  

Sites can download a copy of the amended protocol for IRB review by accessing the RTOG web site at   http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=4637                  

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 the Document History table on the 2nd title page. 

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast.  RTOG recommends re-consenting patients per the site’s local IRB policy. Sites must submit IRB approval for the amendment to CTSU.
 

11/13/2013 1:23:04 PM Subject: RTOG 0522, Amended

Amended
RTOG 0522, “A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas” (a closed study): Amendment 8: In Section 11.1, footnote “L” was amended to limit the CT scan/MRI of the head and neck in follow up to 5 years.

Sites can access the complete summary of changes for this amendment at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=8352                       

Sites can download a copy of the amended protocol for IRB review by accessing the RTOG web site at   http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=4637               

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 the Document History table on the 2nd title page. 

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast.  RTOG recommends re-consenting patients per the site’s local IRB policy. Sites must submit IRB approval for the amendment to CTSU.

 

2/12/2013 1:35:35 PM Subject: RTOG (0324), (0234), (0522), (0617), 0436, and 0920 PROTOCOL NOTICE: NEW Cetuximab Investigator Brochure now available on the website

A NEW Investigator Brochure for Cetuximab, version dated 28 November 2012, is now available on the RTOG website.  The investigator brochure is posted on the website for the following studies under Regulatory Resources: RTOG (0324), (0234), (0522), (0617), 0436, and 0920.  (Example: RTOG 0436 can be found here: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=0436&mode=html&ptid=385)

This version replaces the previous version dated, 2 December-2011.  The Summary of Changes is included within the document beginning on page 2.
Previous versions of the investigator brochures are now being posted on the website: http://www.rtog.org/ResearchAssociates/RegulatoryInformation/InvestigatorBrochureArchive.aspx
 
***The same username and password currently required to view all confidential materials on the RTOG website must be used to access Investigator Brochures***
6/29/2012 10:07:54 AM Subject: RTOG (0234),(0324),(0522),0436, 0617, 0920, 1016 PROTOCOL NOTICE: SAFETY REPORT FOR CETUXIMAB

RTOG has received a safety report for CETUXIMAB.     

Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI
 
The Following RTOG studies involve CETUXIMAB:

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 (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 (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"
 
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”  

RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 GY) VERSUS HIGH-DOSE (74GY) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL +/- CETUXIMAB (IND #103444) IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER”

RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER"
 
RTOG 1016 “PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER”

The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
 
  • Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
  • File a copy of the IND Safety Report in your protocol file.
- MX201110002717_Blinded_Medwatch.pdf
6/18/2012 2:26:48 PM Subject: RTOG (0234),(0324),(0522),0436, 0617, 0920, 1016 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CETUXIMAB

RTOG has received a safety report from NCI for CETUXIMAB.     

Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI
 
The Following RTOG studies involve CETUXIMAB:

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 (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 (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"
 
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”  

RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 GY) VERSUS HIGH-DOSE (74GY) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL +/- CETUXIMAB (IND #103444) IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER”

RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER"
 
RTOG 1016 “PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER”

The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
 
  • Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
  • File a copy of the IND Safety Report in your protocol file.
- Cetuximab_Invstigator_Notification_Eli_Lilly_Manufacturer_Report_#CA201204000069_June_12_2012.pdf
6/1/2012 10:24:30 AM Subject: RTOG (0234),(0324),(0522),0436, 0617, 0920, 1016 PROTOCOL NOTICE: SAFETY REPORT FOR CETUXIMAB

RTOG has received a safety report for CETUXIMAB.     

Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI
 
The Following RTOG studies involve CETUXIMAB:

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 (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 (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"
 
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”  

RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 GY) VERSUS HIGH-DOSE (74GY) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL +/- CETUXIMAB (IND #103444) IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER”

RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER"
 
RTOG 1016 “PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER”

The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
 
  • Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
  • File a copy of the IND Safety Report in your protocol file.
- DE201205004880_MW.pdf
5/18/2012 12:00:50 PM Subject: RTOG (0234),(0324),(0522),0436, 0617, 0920, 1016 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CETUXIMAB

RTOG has received a safety report from NCI for CETUXIMAB.     

Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI
 
The Following RTOG studies involve CETUXIMAB:

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 (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 (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"
 
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”  

RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 GY) VERSUS HIGH-DOSE (74GY) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL +/- CETUXIMAB (IND #103444) IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER”

RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER"
 
RTOG 1016 “PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER”

The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
 
  • Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
  • File a copy of the IND Safety Report in your protocol file.
- Cetuximab_Investigator_Notification_Eli_Lily_Report_#US201201000346_5.10.12.pdf
5/4/2012 10:13:19 AM Subject: RTOG (0234),(0324),(0522),0436, 0617, 0920, 1016 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CETUXIMAB

RTOG has received a safety report from NCI for CETUXIMAB.     

Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI
 
The Following RTOG studies involve CETUXIMAB:

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 (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 (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"
 
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”  

RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 GY) VERSUS HIGH-DOSE (74GY) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL +/- CETUXIMAB (IND #103444) IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER”

RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER"
 
RTOG 1016 “PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER”

The safety report(s) included here do not require revisions to the protocol at this time. A copy must also be retained in the protocol study file.
 
  • Send a copy of the IND Safety Report to your Institutional Review Board (IRB) according to your local IRB’s policies and procedures.
  • File a copy of the IND Safety Report in your protocol file.
- Cetuximab_Investigator_Notification_Eli_Lilly_Report_#US200911000217_4.25.12.pdf

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