December 17, 2018
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NCTN and NCORP CIRB Requirement Policy: Implementation Date Effective March 1, 2019 

As of March 1st, 2019, all sites must be members of the NCI CIRB to enroll patients on any NCTN or NCORP trials. Please click to read our full article and download the NCI document for more information
Our NRG Oncology Semiannual Meeting registration fee is waived, but we still need you to register today!  Read more 
 

Help Celebrate Our Birthday at the NRG Oncology Semiannual Meeting in Phoenix
We hope you can join us for the NRG Oncology Semiannual Meeting and Birthday Celebration, February 7-9, 2019 at the Phoenix Convention Center in Phoenix, AZ. 
Registration deadline is January 14, 2019!

 
Our Gift to You

It’s our birthday, and we are celebrating the reason for our success – our members! We are extending our birthday gift to you. In honor of our 5th birthday, NRG Oncology is waiving the registration fee for all NRG Oncology members - but we still need you to  click here to register today!


ACTIVATION
GYNECOLOGIC
NRG-GY005: Reactivation and Amendment 7; version date: October 12, 2018 (posted on CTSU).

AMENDMENTS
HEAD & NECK

NRG-HN001: Amendment 7 has been approved by Health Canada. Sites in Canada can access the NOL and TPD forms on CTSU.

OTHER PROTOCOL NOTICES

1. BREAST 
NRG-BR002: Kuhn-Hicks Laboratory Holiday Closures 

Winter holiday closure information for the Kuhn-Hicks Laboratory is posted on NRG Oncology.

2. GYNECOLOGIC
GOG-0274/RTOG 1174 OUTBACK: The NHMRC Clinical Trials Centre will be closed from Friday, December 21, 2018 until Tuesday January 8, 2019. Memo posted on NRG Oncology.

Form TR for Biospecimens Shipped to NRG Biospecimen Bank-Columbus
Please note that the NRG Patient ID (e.g., AB###-GY###-#####) must be included on any copies of Form TR shipped to the NRG Biospecimen Bank-Columbus. If the NRG Patient ID does not appear on the top, left of Form TR, please hand-complete the NRG Patient ID before sending the form to the NRG Biospecimen Bank-Columbus. Do not complete the NRG Patient ID for forms accompanying biospecimens shipped laboratories other than the NRG Biospecimen Bank-Columbus. Please contact the NRG Biospecimen Bank-Columbus ( bpcbank@nationwidechildrens.org) if you need assistance or if you have additional questions.

Biospecimen Bank-Columbus & SDMC Undergoing Refurbishment
Please be advised that the data exchange between the Biospecimen Bank-Columbus and SDMC is undergoing refurbishment. During this time, biospecimen receipt information will not appear in Rave or SEDES. Biospecimen transmittal forms (i.e., Form SP and Form TR) will ultimately not appear as overdue during this time; however, there may be a brief period over the next several weeks during which forms may temporarily appear as overdue. If this should occur or if you experience any other issues, please notify Support ( support@nrgoncology.org). Sites should continue to return inquiries from Biospecimen Bank-Columbus staff regarding biospecimen receipt during this time.

3. LUNG
NRG-LU002: Two webinars and associated materials (posted on NRG Oncology).

4. VTOC TRAINING
The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, NRG-HN002, NRG-CC003, and NRG-CC004. Space is limited so register now and reserve your seat. The next training will be held at the Semiannual Meeting on Thursday, February 7, 2019 at 1:00pm MST.

 

 

 

DRUG SAFETY UPDATES and INVESTIGATOR’S BROCHURE NOTICES

 

Safety updates have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE FOR SAFETY REPORTS

INVESTIGATOR’S BROCHURE

Ipilimumab

NRG-BN002

NRG-GY003

NRG

NRG

 

Nivolumab

NRG-BN002

NRG-GY003

NRG

NRG

 

Olaparib

NSABP B-55

CTSU

 

Pembrolizumab

NRG-GI002

NRG-GY016

NRG-HN003

CTSU

CTSU

NRG

 

Pertuzumab

NSABP B-52

 

X (CTSU)

 

 

NCTN and NCORP CIRB Requirement Policy: Implementation Date Effective March 1, 2019
NCI’s National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP) are implementing new requirements for membership in and use of the NCI Central IRB (CIRB). This policy is necessary to bring the NCTN and NCORP programs into compliance with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research ( NOT-OD-16-094). This policy applies to all United States sites enrolling patients in NCTN and NCORP studies and all Groups and Research Bases funded through the NCTN and NCORP programs. As of March 1, 2019, all sites must be members of the NCI CIRB to enroll new patients on any NCTN or NCORP trials. On this date, sites that are not CIRB members will be put in a “suspended” status on the NCTN and NCORP membership rosters and will not be able to enroll new patients to NCTN and NCORP trials. Most NRG Oncology sites are already members of the NCI CIRB but if you are not sure please contact your local IRB. Read more

New deadline for posting national coverage analyses (NCAs) on the CTSU website at trial activation for all Phase II and III NCTN protocols starting January 2, 2019 Read letter here

BB-Columbus Closure on December 17
The NRG Oncology Biospecimen Bank in Columbus will be closed from 12:00-2:00pm ET on Monday, December 17, 2018 for staff to attend a holiday party. If you need to contact the Columbus Biospecimen Bank during this time, please leave a message at 800-347-2486 and you will receive a response as soon as possible.

 

Winter Holiday Closures
Winter holiday closure information for the NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, and McKesson Clinical Research Services is posted on the NRG Oncology website under "News; 2018 Announcements."

 

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.


JOURNAL ARTICLES

Boardman CH, Brady WE, Dizon DS, Kunos CA, Moore KN, Zanotti KM, Matthews C, Cosin JA, Aghajanian C, Fracasso PM. A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes: An NRG Oncology/Gynecologic Oncology Group Study. Gynecol Oncol. 2018 Nov;151(2):202-207.  Read more

 

Dignam JJ, Hamstra DA, Lepor H, Grignon D, Brereton H, Currey A, Rosenthal S, Zeitzer KL, Venkatesan VM, Horwitz EM, Pisansky TM, Sandler HM. Time Interval to Biochemical Failure as a Surrogate End Point in Locally Advanced Prostate Cancer: Analysis of Randomized Trial NRG/RTOG 9202. J Clin Oncol. 2018 Dec 7:JCO1800154. [Epub ahead of print].  Read more

PUBLICATIONS REMINDERS
Please note the following upcoming meeting and abstract submission deadline dates

Upcoming Meetings
American Association for Cancer Research (AACR); Mar 29 - Apr 3, 2019; Atlanta, GA

American Society of Clinical Oncology (ASCO) GI; Jan 17-19, 2019; San Francisco, CA

American Society of Clinical Oncology (ASCO) GU; Feb 14-16, 2019; San Francisco, CA

Society of Gynecologic Oncology (SGO); Mar 16-19, 2019; Honolulu, HI

Society of Surgical Oncology (SSO); Mar 27-30, 2019 ; San Diego, CA

St. Gallen Breast Cancer Conference (SG-BCC); Mar 20-23, 2019; Vienna, Austria

Upcoming Abstract Submission Deadlines
American Association for Cancer Research (AACR); Mar 29 - Apr 3, 2019; Atlanta, GA; LBA submission deadline Jan 10, 2019

American Brachytherapy Society (ABS); Jun 13-15, 2019; Miami, FL; due to publications committee Dec 28, 2018; meeting submission deadline Jan 11, 2019 4pm CT

American Association of Physicists in Medicine (AAPM); Jul 14-18, 2019; San Antonio, TX; due to publications committee Feb 21, 2019; meeting submission deadline Mar 7, 2019

American Society of Clinical Oncology (ASCO); May 31 - Jun 4, 2019; Chicago, IL; due to publications committee Jan 29, 2019; meeting submission deadline Feb 12, 2019; LBA 3-14-19 noon

American Society for Radiation Oncology (ASTRO); Sep 15-18, 2019; Chicago, IL; due to publications committee Jan 30, 2019; meeting submission deadline Feb 13, 2019


ESMO Breast Cancer Annual Congress
; May 2-4, 2019; Berlin, Germany; due to publications committee Jan 16, 2019; meeting submission deadline Jan 30, 2019 TIP, LBA placeholder-Noon CntEuropeTime; LBA deadline Apr 19, 2019

Society of Gynecologic Oncology (SGO); Mar 16-19, 2019; Honolulu, HI; deadline for LBA Jan 7, 2019

St. Gallen Breast Cancer Conference (SG-BCC); Mar 20-23, 2019; Vienna, Austria; meeting submission deadline Dec 15, 2018

NRG Oncology is proud to be an active participant of #CancerMoonShot.
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