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NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for high-risk bone metastases that are not causing symptoms.
If the participant decides to take part in this study, they will either get the usual approach or they will get radiation therapy for up to 5 days plus the usual approach.After the participant finishes treatment, the doctor and study team will continue to follow their condition and watch for side effects. The doctor and study team will check the participant 3, 6, 12, and 24 months after they join the study.
“High-risk” asymptomatic bone metastasis(es)
Patients with any solid tumor type (excluding multiple myeloma)
Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body PET/CT, with radiology report available.
Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment.