RTOG 0631 Phase II/III Study of Image-Guided Stereotactic Radiosurgery for Localized (1-3) Spine Metastases: Phase II Results Samuel Ryu, M.D. 1 , Stephanie L Pugh, Ph.D 2 , Peter C. Gerszten, M.D., MPH 3 , Fang-Fang Yin, Ph.D. 4 , Robert D. Timmerman, M.D. 5 , Ying J. Hitchcock, M.D. 6 , Benjamin Movsas, M.D. 1 , Andrew A. Kanner, M.D. 7 , Lawrence B. Berk, M.D. 8 , David S. Followill, Ph.D. 9 , and Lisa A. Kachnic, M.D. 10 1 Henry Ford Hospital, Detroit, MI 2 RTOG Statistical Center, Philadelphia, PA 3 University of Pittsburgh Medical Center, Pittsburgh, PA 4 Duke University Medical Center, Durham, NC 5 University of Texas Southwestern, Dallas, TX 6 Huntsman Cancer Center, University of Utah, Salt Lake City, UT 7 Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel 8 H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 9 M. D. Anderson Cancer Center, Houston, TX 10 Boston Medical Center MBCCOP, Boston, MA Abstract Purpose—The phase II component of RTOG 0631 assessed the feasibility and safety of spine radiosurgery (SRS) for localized spine metastases in a cooperative group setting. Materials and Methods—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 RT (IGRT) targeting accuracy ≤ 2mm, target volume coverage > 90% of prescription dose, maintaining spinal cord dose constraints (10 Gy to ≤ 10% of the cord volume from 5-6mm above to 5-6mm below the target or absolute spinal cord volume < 0.35cc) and other normal tissue dose constraints. A feasibility success rate < 70% was considered unacceptable for continuation of the phase III component. Based on the one-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 © 2013 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved. Correspondance: Samuel Ryu, M.D., Radiation Oncology, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, sryu1@hfhs.org, Phone: 313-916-1027. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author Manuscript Int J Radiat Oncol Biol Phys. Author manuscript; available in PMC 2013 July 15. Published in final edited form as: Int J Radiat Oncol Biol Phys. 2011 October 1; 81(2): S131–S132. doi:10.1016/j.prro.2013.05.001. NIH-PA Author Manuscript NIH-PA Author Manuscript NIH-PA Author Manuscript