May 09 2022
The NRG-BN001 Study is the First NCI NCTN Proton Therapy Trial to Complete Accrual
The NRG Oncology clinical trial BN001, which is comparing a more dose-intensified radiation therapy schedule to the standard dose of radiation therapy, has recently reached the accrual target. NRG-BN001 is the first National Cancer Institute (NCI)-funded randomized clinical trial of proton therapy within the NCI National Clinical Trials Network (NCTN) to complete accrual.
The study enrolled patients who had a centrally-confirmed, histologically-proven diagnosis of supratentorial glioblastoma (WHO grade IV). The primary objective of
this trial is to determine if dose-escalated and intensified photon IMRT or proton beam therapy with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide. Eligible patients are randomly assigned to either conventional photon irradiation with concomitant and adjuvant temozolomide or dose-escalated and -intensified photon IMRT with concomitant and adjuvant temozolomide at photon centers or the same dose-schedule with protons at proton therapy centers. The photon center cohort reached its target accrual on December 20, 2016.
“Glioblastoma (GBM) is the most common primary malignant brain tumor. The median survival in well-selected patients on clinical trials remains poor at approximately 15-16 months, even with surgery, radiotherapy, and chemotherapy. In the pre-temozolomide era, focal radiotherapy boost techniques such as radiosurgery and brachytherapy have failed to yield significant improvement in survival. However, more modern non-randomized phase 2 data have demonstrated a putative survival advantage when radiotherapy dose-intensification is combined with temozolomide. Further, several pieces of evidence, including a randomized phase 2 trial have demonstrated a lower incidence of acute severe lymphopenia in proton-therapy treated patients, compared to photon therapy, and an indirect survival association with lymphopenia has been established in GBM patients. These data served as the rationale for performing the current trail,” stated Minesh Mehta, MD, Principal Investigator of the NRG-BN001 study, Chair of the NRG Oncology Brain Tumor Committee, and the Deputy Director and Chief of Radiation Oncology at Miami Cancer Institute, a part of Baptist Health South Florida.
“This study investigates whether combining two novel and innovative radiotherapy approaches, proton beam therapy and radiotherapy dose intensification, on the backbone of radiosensitizing temozolomide chemotherapy, overcomes hypoxia-related treatment resistance, limits lymphopenia, and augments local control and thereby survival, ” added Vinai Gondi, MD, Co-Principal Investigator of the NRG-BN001 study, the Director of Research and Education at the Northwestern Medicine Chicago Proton Center, and the Co-Director of the Brain and Spine Tumor Center at the Northwestern Medicine Cancer Center, Warrenville. “Completing the first NRG Oncology and NCI NCTN randomized trial of proton beam therapy is a testament to the mission of NRG Oncology to test novel radiotherapy technologies in clinical trials and to the support of proton centers throughout the U.S. to advance the science of proton therapy”
The Medical Oncology Co-Chair, Antonio Omuro, MD, is performing the final chemotherapy quality review and thereafter, once an adequate number of “events” have been achieved, statistical review will be completed.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI), part of the National Institutes of Health, and is one of five research groups in the NCI’s National Clinical Trials Network.