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

Samuel Ryu, Stephanie L. Pugh, Peter C. Gerszten, Fang Fang Yin, Robert D. Timmerman, Ying J. Hitchcock, Benjamin Movsas, Andrew A. Kanner, Lawrence B. Berk, David S. Followill, Lisa A. Kachnic

Research output: Contribution to journalArticle

99 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)76-81
Number of pages6
JournalPractical Radiation Oncology
Volume4
Issue number2
DOIs
StatePublished - Mar 1 2014

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

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    Ryu, S., Pugh, S. L., Gerszten, P. C., Yin, F. F., Timmerman, R. D., Hitchcock, Y. J., Movsas, B., Kanner, A. A., Berk, L. B., Followill, D. S., & Kachnic, L. A. (2014). RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: Phase 2 results. Practical Radiation Oncology, 4(2), 76-81. https://doi.org/10.1016/j.prro.2013.05.001