May 13 2025
NRG Oncology recently activated NRG-CC014, a pragmatic multicenter randomized phase 3 clinical trial, also known as the “PREEMPT” study. This trial is currently enrolling patients with high-risk bone metastases that are asymptomatic. The trial will compare the effects of adding radiation therapy to the usual care on the occurrence of bone-related complications (such as spinal cord compression, fracture, and surgery for instability) in this patient population.
“Current guidelines support radiation for symptomatic bone metastases, though we observed treatments often occurred after a patient was already hospitalized. We conducted a phase 2 randomized trial showing that radiation therapy reduced subsequent skeletal-related events (SRE) and associated hospitalizations among patients with high-risk asymptomatic bone metastases from solid tumors. The PREEMPT trial was designed as a confirmatory phase 3 randomized trial to be conducted through the NRG Oncology NCORP program,” stated Erin Gillespie, MD MPH, of the University of Washington and the Principal Investigator of NRG-CC014.
“Although evidence suggests that early radiation therapy may be effective in lowering the number of bone metastasis-related complications, it is not known if this approach is superior to usual care. The PREEMPT trial is critical to help understand which patients will benefit the most from early intervention,” added Jonathan T. Yang, MD, PhD, of New York University and Co-principal Investigator of NRG-CC014.
NRG-CC014 will enroll patients with high-risk asymptomatic bone metastases. These patients will be stratified by use of bone modifying agent and histology (breast/prostate vs other), then randomly assigned to receive radiotherapy (Arm 1) or the standard of care (no RT/Arm 2). The primary objective of this study is to assess whether RT to asymptomatic bone metastases reduces subsequent occurrence of SRE (not including RT for pain alone). The study will also compare overall survival, occurrence of SRE including palliative RT, hospitalizations related to SRE, and pain-related quality of life between the study arms.
NRG-CC014 Study Webinar – June 16, 2025
Join the webinar on June 16, 2025, 2-3pm ET, to learn more about the NRG-CC014 (PREEMPT) trial. Please see the flyer for details and register in advance for the webinar. After registering, you will receive an email with the program link.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website
Patient study materials are located on the NRG Oncology website