Randomized Phase III Study Comparing Hypofractionated Stereotactic Radiotherapy to Single-Dose Radiosurgery for Treating Oligometastatic Brain Disease

What this Trial Is About

Researchers are investigating treatments for patients with oligometastatic brain disease, a condition where a limited number of brain metastases occur from systemic cancer. The study focuses on comparing two types of stereotactic radiotherapyhypofractionated stereotactic radiotherapy HSRT and single-dose stereotactic radiosurgery SRSto better preserve neurological function and independence. This randomized phase III trial aims to address the lack of prospective comparison between these two radiation approaches in managing brain metastases from radioresistant cancers such as renal cell carcinoma, sarcoma, and melanoma. Participants will be randomly assigned to receive either HSRT, which delivers 3 doses of 10 Gy over one week, or the historical single-dose SRS, delivering 20 to 25 Gy in one fraction. Both treatments precisely target up to five brain metastases, with lesion sizes between 10 and 25 mm, using a thermoformed mask for treatment delivery. The study also includes medico-economic evaluation and follows established guidelines for patient eligibility, including performance status and neuropsychological ability. During the study, participants will undergo regular assessments including local tumor control measured by RANO-BM criteria at 12 months post-treatment. Researchers will monitor brain toxicities and radionecrosis using standardized criteria over the same period. Participants will have blood tests and brain MRI scans with contrast agents unless contraindicated. The study involves a multidisciplinary approach and requires informed consent, with follow-up visits and evaluations planned for at least one year after treatment to assess effectiveness and safety outcomes.

Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.