July 31, 2023

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WEEKLY HIGHLIGHT

NRG-BR008

The HERO Trial


Study Overview Webinars Scheduled!


Read more


CLOSURE

HEAD & NECK

NRG-HN001: Study Closure Memorandum dated July 21, 2023 (posted on CTSU)


AMENDMENT

GYNECOLOGIC

NRG-GY027: Amendment 1; version date: April 24, 2023 (posted on NRG Oncology and CTSU)


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

NRG-GY022: Reminder: Actively Recruiting MALE Patients only Read More

 

2. BREAST

NSABP B-51/RTOG 1304: Call for submission of data and supporting documentation. Please see the memorandum, dated June 27, 2023, posted on CTSU for additional information.

 

NRG-BR008/HERO: Study overview webinars are being held via Microsoft Teams on August 21st at 11am ET and August 23rd at 3pm ET. Please see the memorandum, dated July 17, 2023 (posted on CTSU) or the July 26th NRG Special Broadcast for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars.

 

NRG-BR008/HERO: Physician Sheet and Protocol Card (posted on CTSU under the “education and promotion” tab).

 

3. GASTROINTESTINAL

NRG-GI002: Call for submission of data and supporting documentation. Please refer to the memorandum, dated July 10, 2023, posted on the CTSU website for additional information.

 

4. GYNECOLOGIC

GOG-0210: Biospecimens, biomarker data, clinical data, and epidemiologic data are available for request. Please visit the NRG Oncology website for more information on this important study with the overall goal of improving the outcome and/or quality of life for patients with endometrial cancer.

 

Printing Biospecimen Transmittal PDFs on GYN Trials

Please note an effort is underway to clarify how to obtain a Biospecimen Transmittal PDF for submission to the NRG Oncology Biospecimen Bank. Read More

 

5. HEAD & NECK

RTOG 1216: The Spanish-translated consent form and CIRB approval of the form are available on CTSU.

 

NRG-HN008: Reminder: Please update treatment and AE data weekly. This is a Phase I trial and timely data submission is very important.

 

6. 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, NRG-CC005, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, August 9, 2023.

DRUG SAFETY AND INVESTIGATOR’S BROCHURE (IB) UPDATES

Drug Safety and Investigator’s Brochure updates have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE

FOR SAFETY REPORTS

IB

UPDATES

AMG-232

NRG-DT001


X

Ipilimumab

NRG-BN007

NRG-GY025

NRG-GU012

NRG-LU002

CTSU

NRG

CTSU

CTSU


Nivolumab

NRG-BN007

NRG-GY025

NRG-GU012

NRG-HN005

NRG-HN007

NRG-LU002


CTSU

NRG

CTSU

CTSU

CTSU

CTSU



*The current version of the Investigator Brochure Documents for Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)-sponsored trials are available for access via the Cancer Therapy Evaluation Program (CTEP) Agent Inventory Management System (AURORA) application. Log-in using your Identity and Access Management (IAM) or ID.me credentials and provide the requested information to access the document.

 

Every site principal investigator is responsible for reviewing this document. The Investigator Brochure is for use by the site principal investigator and any study personnel under his/her supervision who need to know the contents for the conduct of a clinical trial, including Institutional Review Board(s) or Independent Ethics Committee(s).

REGISTER TODAY! The NRG Oncology Brain Metastasis Trial Webinar: Portfolio Review

NRG Oncology Brain Tumor Committee will be hosting a webinar on brain metastasis trials in the NRG Oncology portfolio. This session will be lead by NRG Brain Tumor Committee Chair, Dr. Minesh Mehta, and will feature presentations on NRG-BN012, CCTG CE.7, NRG-CC009, and NRG-BN009. The webinar will be held on August 4, 2023 from 1-2pm ET. Download the webinar flyer here. Register here.


CIRB Study Closure Worksheet Update

The CIRB Study Closure/Transfer of Study Review Responsibility Worksheet has been revised to include the new requirement to confirm each study closure with the Network Group prior to submitting the Study Closure Worksheet. A new question has been added to the CIRB worksheet to allow the attachment of the NRG Request for Early IRB Closure Request form (posted on NRG Oncology).

 

NRG Mentorship Working Group Update

Are you a new CRA or CTN within NRG Oncology? Would you like a mentor to help guide you through your new role as a CRA or CTN? Are you an institution in need of more guidance after an audit? The Mentorship Working Group can provide you a mentor! You can apply for a mentor by going to the Introductory Materials page on the NRG website. You will find the Mentor Form to complete. The instructions on how to submit are located on the form. Hope to hear from you soon!

NRG Oncology is pleased to report the scientific article that appeared during the previous week. This publications report includes the link to this article.

 

JOURNAL ARTICLE

Hall WA, Li J, You YN, Gollub MJ, Grajo JR, Rosen M, dePrisco G, Yothers G, Dorth JA, Rahma OE, Russell MM, Gross HM, Jacobs SA, Faller BA, George S, Al Baghdadi T, Haddock MG, Valicenti R, Hong TS, George TJ. Prospective Correlation of Magnetic Resonance Tumor Regression Grade With Pathologic Outcomes in Total Neoadjuvant Therapy for Rectal Adenocarcinoma. J Clin Oncol. 2023 Jul 21:JCO2202525. doi: 10.1200/JCO.22.02525. Epub ahead of print. PMID: 37478389. Read more.

 

Please note the following upcoming meeting and abstract submission deadline dates


UPCOMING MEETINGS

American Society for Radiation Oncology (ASTRO); Oct 1-4, 2023; Chicago, IL

 

International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB Canada

 

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society of Clinical Oncology (ASCO) GI; Jan 18-20, 2024; San Francisco, CA; due to publications committee Aug 31, 2023; meeting submission deadline Sep 19, 2023, 11:59 pm (EDT); LBA Oct 19, 2023, NOON (EDT)


American Society of Clinical Oncology (ASCO) GU; Feb 16-18, 2023; San Francisco, CA; due to publications committee Sep 6, 2023; meeting submission deadline Sep 26, 2023, 11:59 pm (EDT); LBA Oct 26, 2023, NOON (EDT)


European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey; LBA Aug 7, 2023


European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain; LBA Sep 14, 2023, 9pm CEST


International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea; Abstract & Film; TiP LBA, Aug 21, 2023


San Antonio Breast Cancer Symposium (SABCS); Dec 5-9, 2023; LBA Sep 30, 2023, 11:59 PM (CDT)


Society for NeuroOncology (SNO); Nov 15-19, 2023; Vancouver, Canada; LBA Sep 4, 2023, 5:00 PM (EDT)

 

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