Phase 3 Study Comparing Early Preventive Radiotherapy to Observation for Patients with High-risk, Asymptomatic or Mildly Symptomatic Bone Metastases from Solid Tumors

What this Trial Is About

Researchers are investigating whether preventive radiotherapy can reduce symptoms and complications in patients with metastatic cancer who have high-risk bone metastases that cause no or minimal symptoms. This study focuses on determining if early radiation treatment, in addition to standard medication or observation, can lower the number of skeletal-related events, reduce hospitalizations, improve survival, and enhance quality of life. The study is a multi-center, randomized phase 3 trial involving patients with various solid tumors prone to bone metastases. Participants will be randomly assigned to one of two groups one receiving standard systemic therapy or observation alone, and the other receiving preventive radiotherapy plus standard therapy or observation. Radiotherapy may be a single dose or stereotactic ablative body radiation delivered within 21 days after randomization. During follow-up, patients in the radiotherapy group may receive additional preventative radiation for new high-risk bone metastases, with up to five lesions treated at once. Participants will undergo screening to confirm eligibility, including assessments of medical history, quality of life, and pain for each bone lesion. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months after randomization to monitor safety, efficacy, side effects, medication use, pain, and quality of life through questionnaires. In case of skeletal-related events, assessments will be done promptly, and survival and hospitalization data will continue to be recorded until 24 months post-randomization.

Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases