Phase 3 Study Comparing Single- and Multi-Fraction Stereotactic Radiosurgery for Treating Spinal Metastases

What this Trial Is About

Researchers are evaluating whether fractionated Stereotactic radiosurgery SRS for spinal metastases improves local tumor control compared to single-fraction SRS. This randomized phase III trial involves patients with metastatic cancer affecting the cervical, thoracic, or lumbar spine. The study aims to compare two different radiation dosing schedules to determine which provides better treatment outcomes for spinal metastases. Participants will be randomly assigned to receive either single-fraction spine SRS with 22 Gy in one session or multi-fraction spine SRS with 14 Gy over two sessions. Each spinal site treated will cover 1 to 2 contiguous vertebral levels, and patients may have between one and three separate spinal sites requiring treatment. Both treatments involve precise radiation targeting delivered to the affected spine areas. During the study, participants will be monitored for tumor control one year after treatment. Researchers will also assess quality of life using health questionnaires over two years, pain scores, medication use, adverse effects, vertebral fractures, and rates of local treatment failure at various intervals up to two years. The total expected participation spans up to two years to capture these outcomes and monitor safety and effectiveness of the treatment schedules.

Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases