December 18, 2023

NRG Oncology Broadcast archives are accessible from our website at any time. Please bookmark this link for your convenience.

The NRG Oncology 2024 Winter Meeting is Open for Registration!

The NRG Winter Meeting will be held in-person only at the World Center Marriott in Orlando, FL 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

Winter Symposium - IDEA: Inclusion, Diversity, Equity and Access of Underrepresented Patients to Clinical Trials

Register here for the Winter 2024 Educational Symposium on Thursday, February 15, 2024 from 8am-12pm ET. The symposium will include noted Oncologists and Scientists serving as speakers and moderators. The speakers will focus their presentations on providing a framework for the barriers and solutions to increasing IDEA (Inclusion, Diversity, Equity, and Access) of underrepresented patients to clinical trials. Read more

AMENDMENTS

LUNG

NRG-LU005: Amendment 11; version date: November 13, 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. BRAIN

NRG-BN011: NYU Langone will be closed on Christmas Day Monday 12/25/23 and New Year’s Day Monday 1/1/24. Please plan tissue shipments accordingly.

4. BREAST

NRG-BR008/HERO: Patient-directed press release/recruitment tool dated December 1, 2023 (posted under the CIRB tab on CTSU)

5. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: Memorandum, dated December 18, 2023, regarding Informed Consent Form (posted on CTSU)

NRG-CC010: The study is now open to NRG sites in Japan and South Korea. The optional biospecimen collection does not apply to sites participating in these countries.

6. GENITOURINARY

NRG-GU012: Sites in Canada - The NOL and additional forms for amendment 2-3 are posted on CTSU. Please complete the CTSI and Protocol signature page and submit via the Regulatory submission portal. 

NRG-GU013: Spanish Translated Informed Consent and CIRB approval (posted on CTSU)

7. 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.

NRG-GY031: Please note, there is an error in the section 4.2 table and the Biospecimen Collection and Submission Manual. 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.

8. 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. 

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, NRG-BR009, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, January 17, 2024.

INVESTIGATOR’S BROCHURE (IB) UPDATES

*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 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 nrg-broadcasts@nrgoncology.org.

2. NCI CTEP IAM User Access Update - Deadline Approaching

As a federal requirement, ALL CTEP-IAM USERS must complete identity proofing (IP) and set up multi-factor authentication (MFA) for continued access to NCI systems. U.S.-based NCI Research Staff and Investigators should onboard to ID.me for IP/MFA by January 1, 2024. After January 1st, users will still have system access. However, a final deadline to onboard to ID.me for IP/ MFA will be shared in the upcoming months. Come this deadline date, users will no longer be able to access NCI systems using their CTEP-IAM login credentials. Please go directly to the CTEP-IAM application to get started. For step-by-step instructions, please visit the CTEP website.

3. A022101/ NRG-GI009: Amended to Address Enrollment Barriers

The A022101/NRG-GI009 clinical trial, also known as the “ERASur” study, recently completed a major amendment to help combat identified barriers to patient enrollment. The ERASur trial is a pragmatic randomized phase III study of total ablative therapy for patients with limited metastatic colorectal cancer. The trial will compare the standard treatment for this patient population (systemic therapy alone) to the standard treatment with the addition of total ablative therapy to all remaining metastatic sites.

Eligibility Criteria

• Patients must have newly diagnosed metastatic disease (prior definitive therapy is okay as long as it was completed 12+ months prior to metastatic diagnosis).
• Patients must have < 4 sites of disease on baseline imaging acquired prior to any systemic therapy (no limit to # of lesions per site).
• Patients may register for the study after receiving 16 weeks of systemic therapy and up to a maximum of 26 weeks of systemic therapy.

Current Statistics

• Approved Sites = 77
• Planned Enrollment = 364
• Current Enrollment = 4

More information is available on the ClinicalTrials.gov webpage for this study.



4. Reminder: New NRG Oncology Presentation Slide Templates Now Available

Please start using the 2024 NRG presentation slide template for all presentations on behalf of NRG Oncology or NRG-related work. Download the new slide template here

5. Reminder: Winter Holiday Closure Information

Winter 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 is posted on the CTSU website (Please note: a correction has been issued as the Philadelphia West Operations Office and Philadelphia SDMC office will not be closing early on Friday, December 22.) Please see the updated memoranda dated December 18, 2023 posted under LPO updates for this information.

NRG Oncology is pleased to report the following abstracts that have been accepted for presentation at the upcoming Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer and the American Society for Clinical Oncology (ASCO) GU symposium, respectively. 

ABSTRACTS

Lee JM, Brady M, Miller A, Moore RG, MacKay H, McNally L, Lea JS, Street D, Lheureux S, Bender D, Duska LR, Cantuaria G, Bookman MA, Leath CA III, Powell MA, Cadungog MG, Rose P, Moore KN, Kohn EC. A phase II/III study of cediranib and olaparib combination compared to cediranib or olaparib alone, or standard of care chemotherapy in platinum-resistant ovarian cancer (NRG-GY005). SGO Annual Meeting on Women’s Cancer. Plenary oral presentation. 3/16/2024.

Lukka HR, Pugh SL, Shipley WU, Major PP, Heney NM, Sartor AO, Dayes IS, Bahary J, Efstathiou JA, Pisansky TM, Zeitzer KL, Lawton CA, Dess RT, Camarata AS, Balogh AG, Souhami L, Rosenthal SA, Seiferheld WF, Feng FY, Sandler HM. Long term results of radiation with or without anti-androgens (AAT) in patients receiving salvage prostate bed radiation therapy(sRT) post prostatectomy. American Society for Clinical Oncology (ASCO) GU. Poster presentation. 1/25/2024. 

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

Society for Clinical Trials (SCT); May 19-22, 2024; Boston, MA

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

Society of Surgical Oncology (SSO); Mar 20-23, 2024; Atlanta, GA

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

UPCOMING ABSTRACT SUBMISSION DEADLINES

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

American College of Radiology (ACR); Apr 13-17, 2024; Washington, DC; submission deadline Dec 15, 2023

American Society of Clinical Oncology (ASCO); Chicago, IL; due to publications committee Jan 23, 2024; submission deadline Feb 6, 2024, 11:59 pm ET; LBA Mar 11, 2024, 11:59 pm ET (placeholder required)

American Society for Radiation Oncology (ASTRO); Sep 29-Oct 2, 2024; Washington, DC; due to publications committee Feb 27, 2024; submission deadline Mar 12, 2024; LBA Jul 12, 2024

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

European Society for Medical Oncology (ESMO); Sep 13-17, 2024; Barcelona, Spain; due to publications committee Apr 23, 2024; submission deadline May 7, 2024, 21:00 CET; LBA Aug 7, 2024, 21:00 CET (placeholder required)

European Society for Medical Oncology (ESMO) Breast Cancer; May 15-17, 2024; Berlin, Germany; due to publications committee Jan 30, 2024; submission deadline Feb 13, 2024, 21:00 CET; LBA Apr 17, 2024, 21:00 CET (placeholder required)

European Society for Medical Oncology (ESMO) Gastrointestinal; Jun 26-29, 2024; Munich, Germany; due to publications committee Jan 30, 2024; submission deadline Apr 9, 2024, 21:00 CET; LBA Jun 6, 2024, 21:00 CET (placeholder required)

European Society for Medical Oncology (ESMO) Gynaecological; Jun 20-22, 2024; Florence, Italy; due to publications committee Mar 20, 2024; submission deadline Apr 3, 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