November 13, 2023

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NRG Winter 2024 Meeting


Registration is now open!


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The NRG Oncology 2024 Winter Meeting is Open for Registration!

The Meeting will be held in-person only in Orlando from Thursday, February 15, 2024 - Saturday, February 17, 2024 with select virtual session offerings. Please visit our meeting webpage for the agenda and more information. Register here

 

Now Accepting Travel Award Applications

Travel award applications have been consolidated into one form. All applications must be received by November 22, 2023 at 5pm ET. Awardees will be notified in late November. Please be sure to attach any required materials, when applicable, to complete your application. More information and application

ACTIVATIONS

GENITOURINARY

NRG-GU013: Activation Date November 13, 2023 (posted on CTSU)


AMENDMENT

CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: Amendment 5; version date October 20, 2023 (posted on CTSU)


CLOSURES & SUSPENSIONS

HEAD & NECK

NRG-HN005: Temporary Closure Notice, dated November 08, 2023 (posted on CTSU)


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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

 

2. BIOSPECIMEN BANK

Printing Biospecimen Transmittal PDFs from Rave

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

 

3. BREAST

NRG-BR008/HERO: Study overview webinars are being held via Microsoft Teams on November 28th at 3pm ET and November 29th at 11am ET. Please see the memorandum, dated October 26, 2023, (posted on CTSU) for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars. 


4. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: FORTE site tool- Baseline Visit Checklist” document has been posted on CTSU. This document is a tool for research professionals to use in preparation to consent and randomize a participant to NRG-CC005. NRG encourages sites to customize this document based on local processes.


NRG-CC008/SOROCk: There are 10 slots remaining for the 35- <42 age block of the BSO arm. Once these slots are filled accrual will be temporarily held to allow the 35- <42 age block of the BLS arm to enroll the same number of patients. This age blocking is specified in the protocol to ensure equal distributions of patients because this is a non-randomized study. Please see protocol Section 14.5 for a description of the age blocking. 


The BSO arm, for the 35- <42 age block, will re-open once 49 more BLS arm patients are enrolled to that cohort. 


5. GASTROINTESTINAL

NRG-GI008/CIRCULATE-North America: Updated Patient Webpage and Study Overview Brochure (posted on NRG Oncology website)

 

NRG-GI008/CIRCULATE-North America: Natera Thanksgiving Holiday closure (posted on CTSU)


6. GYNECOLOGIC

GOG-0210: Reminder: 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.

 

GOG-0225 and GOG-0278: In preparation for final analysis, sites are asked to address all outstanding queries by November 30, 2023 so data analysis can commence. Data queries for GOG-0278 were sent in Medidata Rave and can be responded to in Rave. Queries for GOG-0225 were sent in SEDES and must be replied to in SEDES. If site personnel need access to SEDES for this study, please contact [email protected]. SEDES can be accessed via the GOG Web Menu. The queries issued are imperative to analysis. Your help at this busy time of year is much appreciated! Please contact Linda Gedeon at [email protected] with any questions regarding data entry.


NRG-GY018: Data Collection is currently in progress. All institutions that have enrolled patients on the NRG-GY018 study, regardless of current status, will need to keep the study open with their IRB’s. Please see memo posted on CTSU.

 

NRG-GY031: Please note, there is an error in the section 10.1.1 biospecimen collection table. The Part I PK collection is to be done on Cycle 1, Day 1, and Cycle 1, Day 8. This will be updated with the next amendment.

 

7. HEAD & NECK

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

 

8. LUNG

NRG-LU008: The webinar recording from October 30, 2023 is now posted on the study webpage of NRG Oncology (Documents and Materials tab).


9. 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 December 13, 2023.

DRUG SAFETY AND INVESTIGATOR’S BROCHURE (IB) UPDATES

DRUG NAME

PROTOCOL

WEBSITE FOR SAFETY REPORTS

INVESTIGATOR'S

BROCHURE (IB)*

Darolutamide

NRG-GU010

CTSU


Durvalumab

NRG-GY012

NRG-GY023

NRG-HN004

NRG-LU004

RTOG 1308

CTSU

CTSU

CTSU

NRG

CTSU


Tremelimumab

NRG-GY021


X

*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).

1. NRG Oncology Confidential Member Survey

Please read our survey FAQ’s. All NRG Members should have received an email from the University of Chicago’s Survey Lab <[email protected]> containing a unique survey link. If you have not already completed the survey please check your inbox and possibly your spam/junk mailbox for the email so that you can help us collect this important information. Please send any additional questions to [email protected].

 

2. NRG-CC011 Study Overview Webinar – Register Today!

NRG Oncology is hosting a webinar for a developing trial, NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial. This session will be held on December 5, 2023, 12 – 1pmEST, and led by the study chairs, Dr. Diane Von Ah, Dr. Patricia Ganz and Dr. Brenna McDonald. This trial is designed to examine whether computerized training will improve cancer-related cognitive impairment, including the ability to concentrate, learn new things, remember, and make decisions that affect daily life in breast cancer survivors. Activation is anticipated late 2023/early 2024. 


Click here to register in advance for this meeting


After registering, you will receive a confirmation email containing information about joining the meeting.


3. Press Release: FORTE accrues its first 1,000 participants

The FORTE Study Team is excited to announce that FORTE accrued its 1000th participant on October 30, 2023. With over 30 sites actively accruing patients, we continue to expand our network of clinical research sites screening patients for FORTE. Read the Press Release



4. Thanksgiving Holiday Closure Information

Please see the memoranda posted on the CTSU website for Thanksgiving holiday closure information for the NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, Serum Bank, and McKesson's Clinical Research Services.


NRG Oncology is pleased to report the following abstracts accepted as posters and oral presentations at the American Society of Clinical Oncology (ASCO) GI 2024 symposium this coming January.


ACCEPTED ABSTRACTS

Lieu CH, Yu G, Kopetz S, Jacobs SA, Lucas PC, Sahin IH, Deming DA, Philip PA, Hong TS, Rojas-Khalil Y, Loree J, Wolmark N, Yothers G, George TJ, Dasari A. NRG-GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US). ASCO GI Poster Presentation. 1/18/2024. Abstr. TPS231.


Morris VK, Yothers G, Kopetz S, Puhalla SL, Lucas PC, Iqbal A, Boland PM, Deming DA, Scott AJ, Lim HJ, Hong TS, Wolmark N, George TJ. Phase II results of Circulating tumOr DNA as a predictive BiomaRker in Adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) Phase II/III Study. ASCO GI Oral Presentation. 1/18/2024. Abstr. 5.


Overman MJ, Yothers G, Jacobs SA, Sanoff HK, Cohen DJ, Guthrie KA, Henry NL, Ganz PA, Kopetz S, Lucas PC, Blanke CD, Hong TS, Wolmark N, Hochster HS, George TJ, Rocha Lima C. COlorectal cancer metastatic dMMR Immuno-Therapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/ atezo in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC): NRG-GI004/SWOG-S1610. ASCO GI Poster Presentation. 1/18/2024. Abstr. TPS231.


Please note the following upcoming meeting and abstract submission deadline dates

 

UPCOMING MEETINGS

American Association for Thoracic Surgery (AATS); Apr 27-30, 2024; Toronto, ON


American Head & Neck Society (AHNS); May 15-16, 2024; Chicago, IL


American Radium Society (ARS); May 2-5, 2024; Palm Springs, CA


American Society of Breast Surgeons (ABS); Apr 10-14, 2024; Orlando, FL


American Society of Clinical Oncology (ASCO) GI; Jan 18-20, 2024; San Francisco, CA


American Society of Clinical Oncology (ASCO) GU; Jan 25-27, 2024; San Francisco, CA


American Society of Colon and Rectal Surgeons (ASCRS); Jun 1-4, 2024; Baltimore, MD


Radiological Society of North America (RSNA); Nov 26-30, 2023; Chicago, IL


San Antonio Breast Cancer Symposium (SABCS); Dec 5-9, 2023; San Antonio, TX


Society of Gynecologic Oncology (SGO); Mar 16-18, 2024; San Diego, CA


Society for Neuro-Oncology (SNO); Nov 15-19, 2023; Vancouver, BC


Society of Surgical Oncology (SSO) - Advanced Cancer Therapies (ACT); Feb 16-19, 2024; San Juan, Puerto Rico


Society for Urologic Oncology (SUO); Nov 28-Dec 1, 2023; Washington, DC

 

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association for Cancer Research (AACR); Apr 5-10, 2024; San Diego, CA; submission deadline Nov 16, 2023, 11:59 pm ET; LBA Jan 8, 2024, 11:59 pm ET


American College of Radiology (ACR); Apr 13-17, 2024; Washington, DC; due to publications committee Jan 2, 2024; submission deadline Jan 15, 2024


European Society of Gynaecological Oncology (ESGO); Mar 7-10, 2024; Barcelona, Spain; submission deadline Nov 13, 2023; LBA Jan 15, 2024


ESMO Breast Cancer; May 15-17, 2024; Munich, Germany; due to publications committee; submission deadline Feb 13, 2024, 21:00 CET; LBA Apr 17, 2024, 21:00 CET (placeholder required)


European Society for Radiotherapy and Oncology (ESTRO); May 3-7, 2024; Glasgow, Scotland; LBA Jan 24, 2024


Oncology Nursing Society (ONS); Apr 24-28, 2024; Washington, DC; LBA Jan 11, 2024


Society for Clinical Trials (SCT); May 19-22, 2024; Boston, MA; due to publications committee Nov 17, 2023; submission deadline Dec 1, 2023, 11:59 pm ET


Society of Surgical Oncology (SSO); Mar 20-23, 2024; Atlanta, GA; LBA Dec 6, 2023, 11:59 pm ET


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