Study Comparing Single-Session vs Multi-Session SBRT for Treating Oligometastatic Breast, Prostate, Lung, and Colorectal Cancers

What this Trial Is About

Researchers are investigating the use of single-fraction stereotactic body radiotherapy SBRT compared to the current standard multiple-fraction SBRT for patients with oligometastatic disease from primary breast, prostate, non-small cell lung cancer NSCLC, and colorectal cancer. This study aims to determine if a single high-dose radiation session is as safe and effective as multiple treatment sessions. The trial is part of the OligoCare project within the E-RADIatE platform, which collects real-world data on SBRT in this patient population. Participants will be randomly assigned to receive either single-fraction SBRT or multiple-fraction SBRT. Single-fraction SBRT delivers a high dose of radiation in one visit, with doses ranging from 16 Gy to 34 Gy depending on the metastasis location. Multiple-fraction SBRT spreads the radiation dose over several sessions. The treatment duration varies based on the number of metastases treated. Both approaches target all lesions with radical intent. During the study, participants will be monitored for safety and treatment outcomes, including grade 3 or higher SBRT-related toxicity within 12 months after treatment. Researchers will also assess progression-free survival, overall survival, local control of metastases, and patterns of disease progression over 4.5 years. The trial will involve regular assessments and follow-ups to evaluate these outcomes and the overall impact of the treatments.

OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)