October 2023

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Welcome to the NRG Oncology eNewsletter

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Breast Cancer Awareness Month

NRG-BR009 The OFSET Study

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression and Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score of ≤ 25

Recently activated & now enrolling patients!

The NRG-BR009 (“OFSET”) trial will be evaluating whether adjuvant chemotherapy added to ovarian function suppression and endocrine therapy is superior to ovarian function suppression and endocrine therapy alone in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early-stage breast cancer patients with ER-positive, HER2-negative tumors and a 21-gene recurrence score between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). This study will answer a decades old question regarding the benefit of chemotherapy, whether from cytotoxic effects or ovarian suppressive effects.


Written by Shannon Puhalla, MD; NRG-BR009 Protocol Officer

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NRG Oncology Breast Cancer trials


NRG-BR008 / The HERO Study: A Phase III Randomized Trial Seeking to Optimize Use of Radiotherapy in Patients with Early-Stage, Low Risk, HER2-Positive Breast Cancer Now enrolling patients!



There has long been a movement in radiation oncology to identify patient populations least likely to benefit from adjuvant radiotherapy in order to scale back the use of radiotherapy in those patient populations. In recent years, this effort has begun to be met with success—two examples being “good risk” DCIS patients and favorable-risk older patients with small, node-negative, biologically less aggressive (hormone receptor-positive and HER2-negative) invasive cancers. Read more


Watch for our interview with Dr. Lior Braunstein (NRG-BR08 Principal Investigator):

NRG-BR007 / The DEBRA Study: A Phase III Clinical Trial Evaluating the De-escalation of Breast Radiation for a More Conservative Treatment of Patients With Low-Risk, Hormone-Sensitive, Node-Negative Breast Cancer Now enrolling patients!



Over the last three decades, radiotherapy has become an established part of the paradigm for breast conservation in early-stage breast cancer. Recognizing that the toxicity and patient burden associated with a protracted course of radiotherapy are potential barriers to the use of breast conservation, investigators have made multiple attempts to identify subsets of patients who do not derive a significant benefit from radiotherapy and could therefore be spared from receiving it. Read more


Watch for our interview with Dr. Julia White (NRG-BR007 Principal Investigator) in an upcoming newsletter.

Member News

AI 101 interview with Dr. Patricia Ganz

Patricia Ganz, MD, director of cancer prevention and control research at UCLA Jonsson Comprehensive Cancer Center, was recently interviewed by Katie Couric about Aromatase Inhibitors. Read the interview.

Video Interview Feature

NRG-HN009 Video Interview with Dr. Harari

Currently enrolling patients, NRG-HN009 is a randomized Phase II/III trial comparing cisplatin every three weeks to cisplatin weekly when combined with radiation for patients with advanced head and neck cancer. Watch as Dr. Paul Harari, principal investigator for NRG-HN009, provides an overview about this important clinical trial.

New Protocols Under Development

The NRG Oncology chart of new protocols under development includes the study’s disease site, title, Principal Investigator, and any comments pertaining to the study’s anticipated activation.


The updated listing as of September 30, 2023 can be found here.

NCORP Pilot Grant Process (2023-2024)

NRG Oncology NCORP committee leaders will host a pilot grant workshop during the NRG Oncology Winter meeting, February 15-17, 2024. An informational session was held on September 11, 2023 and the recording along with slides are now available here:



The request for funding application (RFA) for NCORP pilot projects will be released in Spring 2024. However, anyone interested in applying for this RFA must submit a Letter of Intent (LOI); due November 3, 2023. Click here to download the form


NCORP committee chairs will review LOIs and select those best aligned with committee goals, NCORP priorities and feasible. 


Selected investigators will be notified and invited to attend a workshop at #NRG2024 Winter Meeting in Orlando, Florida; February 15-17, 2024 (date/time TBD)

Megan Mullins, PhD, NRG Cancer Care Delivery Researcher, Examines Health Equity Issues in Latest Publication

Dr. Megan Mullins, NRG’s Cancer Care Delivery Research (CCDR) committee member, continues advancing health equity with her latest publication, “Barriers, Facilitators, and Recommendations, for Sexual Orientation and Gender Identity Data Collection in Community Oncology Practices”.1 Beyond her commitment to this pressing challenge, Dr. Mullins exemplifies a commitment to team science. 

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PCOR Committee Educational Session at #NRG2024 Orlando

 

At the NRG Oncology Winter Meeting in February 2024, the Patient Centered Outcomes Research (PCOR) Committee will be offering an educational session for NRG investigators interested in learning about the basics of how to design patient reported outcomes (PROs) components for future NRG trials.

 

This educational session is designed to broaden the PRO knowledge among NRG investigators. Some of the topics that will be covered in this session will include the following: how to select appropriate PRO measures for each trial; how to design hypothesis-testing PRO components for a trial; the NCI review and approval process for PRO components; basic statistical considerations, etc.

 

This PRO educational session is open to anyone at NRG who is interested. This is a “mini-training” session, as there is a lot more to learn over time regarding PROs.This PRO educational session will be part of the PCOR Committee meeting, which usually is scheduled on Thursday afternoon during the NRG Oncology Meeting.

Protocol Support Committee (PSC) Column

Informed Consent Guidance Now Available

Written by: Donna White RN, BSN, OCN, and Megan Park, Research Coordinator III, Cleveland Clinic and Mary Jo Antonelli, MBA, MHA, Director of Quality Assurance and Operational Support, NRG Oncology

In this post COVID-19 pandemic world, many are asking about the use of remote consenting for clinical trial participation. In the March 23, 2020, memorandum from NCI an initial allowance for “Alternative Procedures for Informed Consent for Trials” was provided. Stating that the NCI CIRB supported a ‘remote’ informed consent process as COVID-19 control measures.

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NRG Oncology News

JCO 40th Anniversary “Flashback” Series

To celebrate its 40th anniversary, the Journal of Clinical Oncology (JCO) is looking back at the history-making research that it has published over the past 40 years. JCO is republishing in each issue throughout this year the top 10 most cited manuscripts in its entire history. We are honored to be included in this distinguished group of practice changing research articles that have changed the landscape of cancer treatment over the past 40 years.


Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 2023 Apr 1;41(10):1795-1808. doi: 10.1200/JCO.22.02571. PMID: 36989610. Read more.


Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino JP, Geyer CE Jr, Wickerham DL, Wolmark N. Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor-Positive Breast Cancer. J Clin Oncol. 2023 Jul 10;41(20):3565-3575. doi: 10.1200/JCO.22.02570. PMID: 37406456. Read more.

NRG Oncology at #ASTRO23

NRG Oncology had 20 presentations at ASTRO's Annual Meeting, held October 1-4, 2023, in San Diego, including a Master Class, two plenary presentations, four Presidential Symposium sessions, and eight oral presentations. View the NRG broadcast listing of highlighted NRG Oncology presentations here.

NRG Oncology-RTOG 1308 Accrual Completion

First Phase III NCTN Clinical Trial Comparing Photon Versus Proton Therapy to Meet Accrual Target

Read the Full Press Release

Does your site have NRG-CC005 activated? Are you looking for more support from NRG for FORTE?

NRG offers a one-time site network start-up award of $5,000 to enhance recruitment. Sites will need to document their plans for building their FORTE referral network and their commitment to the FORTE trial. These funds are intended to assist in establishing a clinical referral population and to institute workflows to facilitate recruitment and enrollment. Funding is contingent upon review by the NRG FORTE leadership team.

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FORTE now has a mascot!


Sites can use our mascot to promote this important colorectal cancer prevention clinical trial on patient-directed materials, social media, and more. Find it on CTSU under “Logo and Mascot (version 06/01/23)” from June 23, 2023.