NRG Oncology Trials that Recently Met Their Accrual Goals

06/22/2026

Congratulations to all of the NRG Oncology trials that recently reached their accrual goal milestones! A special thank you to all of the study teams, sites, research staff, and especially our patients and their families for accruing to these very important studies.

NRG-BR007: A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

“Although lumpectomy and radiotherapy has become the accepted standard for breast conserving treatment as an alternative to mastectomy, it is now time to reconsider the additional benefit of radiation in some cases given the ability to identify Stage I, hormone sensitive, HER2-negative breast cancer patients at very low risk of recurrence through subtyping and/or combined with multigene tumor assays like the Recurrence Score. There is a need to address the potential overtreatment of patients with radiation post lumpectomy and recognized barriers of the treatment with regard to toxicity and patient burden.”

-Julia White, MD, Principal Investigator of the NRG-BR007 trial.

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

“We are delighted not only in the breadth of clinical sites and investigators who participated, but in the pace of accruals for NRG CC14: enrollment completed in less than half the anticipated time, despite early concerns about clinical equipoise and the 1:1 randomized design. This speaks to the critical need for clinicians and patients to define the optimal role of early radiation for asymptomatic bone metastases. While closing enrollment is a major milestone, ongoing patient followup and collection of skeletal events as the primary outcome will be critical to ensuring the trial’s success and ability to inform clinical practice and further research.”

-Erin Gillespie, MD, and Jonathan Yang, MD, Principal Investigators of the NRG-CC014 trial.

NRG-GI003: A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma

“The generation of level 1 evidence for proton therapy is important for the field of radiation oncology. The completion of NRG-GI003 will provide important information and understanding about the role that proton therapy may have in the management of liver cancer. The completion of this study also highlights the vital role that the NCTN and NRG play in answering timely questions that affect the lives of our patients.”

-Theodore “Ted” Hong, MD, Principal Investigator of the NRG-GI003 trial.

NRG-GU008: Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy

“Node-positive prostate cancer is a potentially curable form of Stage 4 prostate cancer but patient outcomes are suboptimal because very few clinical trials have focused on this patient population. NRG-GU008 is significant because it is the largest trial to date dedicated to improving the cure rates for patients with node-positive prostate cancer.”

-Ronald Chen, MD, Principal Investigator of the NRG-GU008 trial.

NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

“The completion of NRG-GU010 accrual ahead of schedule — exceeding 2,000 patients in approximately four years — reflects the importance the genitourinary oncology community continues to place on practical, cooperative group-led efforts addressing patient-centered questions in treatment personalization.

This study leverages genomic risk stratification (Decipher) to address the recognized heterogeneity within unfavorable intermediate-risk prostate cancer, helping determine not only the appropriate intensity of androgen deprivation therapy, but whether it is needed at all. At the same time, the trial evaluates the potential benefit of treatment intensification with darolutamide in genomically higher-risk subgroups. The overarching goal is clear: preserve quality of life where escalation is unnecessary while maximizing benefit where additional therapy may matter most.

A permissive radiotherapy approach, combined with integration of modern treatment techniques and robust NRG radiation therapy quality assurance, facilitated broad participation across diverse practice settings and geographic regions. The commitment of patients, investigators, research teams, and the broader NRG network positions this study to generate practice-changing evidence for one of the most common and often challenging treatment decisions in curative-intent prostate cancer care.”

-Neil Desai, MD, and Alejandro Berlin, MD, Principal Investigators of the NRG-GU010 trial.

NRG-GU011: A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy with or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

“The study team and I are excited that we completed accrual to NRG GU011 earlier this year. This study is important because it tests the interaction between short course testosterone suppression and metastasis directed ablative radiotherapy (MDT). A few studies have come out since this study was designed, but our design will add to these because it specifically evaluates both cancer outcomes (radiographic progression-free survival is the primary endpoint) and quality of life outcomes so it will educate us as radiation oncologists so we can better educate our patients as to the pros and cons of MDT with or without hormonal therapy.”

-Bridget Koontz, MD, Principal Investigator of the NRG-GU011 trial.