Comparing Separation Surgery Plus Stereotactic Ablative Body Radiotherapy to Stereotactic Ablative Body Radiotherapy Alone for Treating Spinal Metastases Invading the Spinal Canal

What this Trial Is About

Researchers are investigating how stereotactic ablative body radiotherapy SABR alone compares to separation surgery followed by SABR in patients with malignant epidural spinal cord compression MESCC who can walk with or without aid. This randomized controlled trial focuses on maintaining walking ability three months after treatment, with additional goals including local tumor control, progression-free survival, pain relief, quality of life, and the need for further interventions. Participants are randomly assigned to one of two groups one receives separation surgery followed by SABR, and the other receives SABR alone. Surgery aims to remove tumor tissue pressing on the spinal cord to allow safer radiation delivery. SABR is given in five treatment sessions, each delivering specific radiation doses to targeted areas. Surgery is scheduled within 21 days post-randomization, and SABR starts within 21 days either after surgery or alone. Throughout the study, participants are closely monitored through various methods including MRI scans, clinical evaluations, questionnaires on quality of life and pain, and teleconsultations at multiple time points up to two years after treatment. These assessments track ambulatory function, treatment side effects, tumor control, need for additional treatments, and survival. The total study period includes screening, treatment, and follow-up phases lasting up to 24 months.

Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases