RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: Phase 2 results

Purpose: The phase 2 component of Radiation Therapy Oncology Group (RTOG) 0631 assessed the feasibility and safety of spine radiosurgery (SRS) for localized spine metastases in a cooperative group setting. Methods and Materials: Patients with 1-3 spine metastasis with a Numerical Rating Pain Scale (NRPS) score ≥. 5 received 16 Gy single fraction SRS. The primary endpoint was SRS feasibility: image guidance radiation therapy (IGRT) targeting accuracy ≤. 2 mm, target volume coverage >. 90% of prescription dose, maintaining spinal cord dose constraints (10 Gy to ≤. 10% of the cord volume from 5-6 mm above to 5-6 mm below the target or absolute spinal cord volume < 0.35 cc) and other normal tissue dose constraints. A feasibility success rate < 70% was considered unacceptable for continuation of the phase 3 component. Based on the 1-sample exact binomial test with α = 0.10 (1-sided), 41 patients were required. Acute toxicity was assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0. Results: Sixty-five institutions were credentialed with spine phantom dosimetry and IGRT compliance. Forty-six patients were accrued, and 44 were eligible. There were 4 cervical, 21 thoracic, and 19 lumbar sites. Median NRPS was 7 at presentation. Final pretreatment rapid review was approved in 100%. Accuracy of image guided SRS targeting was in compliance with the protocol in 95%. The target coverage and spinal cord dose constraint were in accordance with the protocol requirements in 100% and 97%. Overall compliance for other normal tissue constraints was per protocol in 74%. There were no cases of grade 4-5 acute treatment-related toxicity. Conclusions: The phase 2 results demonstrate the feasibility and accurate use of SRS to treat spinal metastases, with rigorous quality control, in a cooperative group setting. The planned RTOG 0631 phase 3 component will proceed to compare pain relief and quality of life between SRS and external beam radiation therapy.