OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)

What this Trial Is About

Researchers are studying spinal metastases, which are cancer spread to the spine, and evaluating whether adding an extra dose of radiation (called a radiation boost) to standard spine stereotactic body radiation therapy (SBRT) can better control tumors, reduce pain, and minimize long-term side effects. This is a Phase II trial sponsored by Sunnybrook Health Sciences Centre focused on improving outcomes for patients receiving radiation for spinal metastases. Participants receive a radiation boost targeted to the affected spinal area. The boost dose depends on the number of radiation treatment sessions normally prescribed; for example, if 2 sessions are planned, an additional 2 Gy is given, and similarly for 4 or 5 sessions. This boost is delivered along with the usual SBRT treatment. The study includes patients with spinal metastases who may have had surgery but no prior radiation to the treated spinal level. During the study, participants will be monitored for disease progression in the treated spine area for up to 12 months following radiation. Researchers will also assess pain levels at 3 and 6 months, side effects related to treatment, and spinal stability using specific scoring tools. Patients will complete pain and medication diaries and attend follow-up visits to track outcomes and safety. Treatment must begin within 14 days of radiation planning, and participants must be able and willing to complete the study activities.

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases