December 11, 2023

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NRG-BR008, HERO Study Seeks to Optimize use of Radiotherapy in Patients with Early-Stage, Low Risk, HER2-Positive Breast Cancer


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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

CLOSURES & SUSPENSIONS

LUNG

NRG-LU002: Permanently Closed to Accrual Study Memorandum, dated December 6, 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: Slides from the Study Overview Webinars held in November (posted on CTSU)

 

5. CANCER PREVENTION & CONTROL

NRG-CC008/SOROCk: Accrual for the 35- <42 age block of the BSO cohort, is being temporarily withheld until the 35-<42 BLS age block enrolls 189 patients. Age blocking is specified in the protocol to ensure equal distributions of patients, because this is a non-randomized study. Please refer to protocol section 14.5 for description of the age blocking.


The BLS arm for the 35- <42 age block remains open for accrual.


The BSO arm, for the 35- <42 age block, will re-open once 41 more patients are enrolled on the BLS 35- <42 arm. It is anticipated that this will take approximately six months.


6. GASTROINTESTINAL

NRG-GI008/CIRCULATE-North America: Memorandum re: Natera Winter Holiday closures (posted on CTSU)


7. GENITOURINARY

NRG-GU012: Reminder! This phase II trial for patients with metastatic unresected renal cell cancer is open to enrollment. The study is open to all NCTN member sites in the U.S and Canada. Please help us enroll. Protocol documents are posted to the CTSU website.


RTOG-0534: The AUA Symptom Index Questionnaire results are no longer being collected. Please see the study memorandum, dated December 05, 2023, in CTSU.


8. 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.


9. 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. 


10. 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 here now and reserve your seat. The next webinar training is scheduled for Wednesday, December 13, 2023.

 

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

  

1. 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.



2. News Release: NRG-BR008, the HERO Study, seeks to optimize use of radiotherapy in patients with early-stage, low risk, HER2-positive breast cancer. Read more

 

3. 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 see the memoranda dated December 11, 2023 posted under LPO updates for this information).


4. 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. NRG-CC011 Pre-activation Webinar Recording Available

The NRG-CC011 clinical study of cognitive training for cancer-related cognitive impariment will be activating soon. The NRG-CC011 study team recently held a webinar to overview the study prior to its activation. Watch the recording of the webinar here on NRG Oncology’s YouTube channel.

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


JOURNAL ARTICLES

Batchelor TT, Won M, Chakravarti A, Hadjipanayis CG, Shi W, Ashby LS, Stieber VW, Robins HI, Gray HJ, Voloschin A, Fiveash JB, Robinson CG, Chamarthy U, Kwok Y, Cescon TP, Sharma AK, Chaudhary R, Polley MY, Mehta MP. NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma. Neurooncol Adv. 2023 Oct 11;5(1):vdad116. doi: 10.1093/noajnl/vdad116. PMID: 38024244; PMCID: PMC10660192. Read More.


Lee SH, Geng H, Arnold J, Caruana R, Fan Y, Rosen MA, Apte AP, Deasy JO, Bradley JD, Xiao Y. Interpretable Machine Learning for Choosing Radiation Dose-volume Constraints on Cardio-pulmonary Substructures Associated with Overall Survival in NRG Oncology RTOG 0617. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1270-1286. doi: 10.1016/j.ijrobp.2023.06.009. Epub 2023 Jun 19. PMID: 37343707. Read More.


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; Munich, 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) 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

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