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 thoracic and 19 lumbar sites. Median NRPS was 7 at presentation. Final pre-treatment 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. CONCLUSION: The phase II 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 III component will proceed to compare pain relief and quality of life between SRS and external beam radiotherapy.
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 thoracic and 19 lumbar sites. Median NRPS was 7 at presentation. Final pre-treatment 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. CONCLUSION: The phase II 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 III component will proceed to compare pain relief and quality of life between SRS and external beam radiotherapy.
Authors: Manuel Valdivieso; Benjamin W Corn; Janet E Dancey; D Lawrence Wickerham; L Elise Horvath; Edith A Perez; Alison Urton; Walter M Cronin; Erica Field; Evonne Lackey; Charles D Blanke Journal: Semin Oncol Date: 2015-07-10 Impact factor: 4.929
Authors: Morten H Suppli; Per Munck Af Rosenschold; Helle Pappot; Benny Dahl; Søren S Morgen; Ivan R Vogelius; Svend A Engelholm Journal: J Radiosurg SBRT Date: 2016
Authors: Adam N Wallace; Clifford G Robinson; Jeffrey Meyer; Nam D Tran; Afshin Gangi; Matthew R Callstrom; Samuel T Chao; Brian A Van Tine; Jonathan M Morris; Brian M Bruel; Jeremiah Long; Robert D Timmerman; Jacob M Buchowski; Jack W Jennings Journal: Oncologist Date: 2015-09-09
Authors: Jacob A Miller; Ehsan H Balagamwala; Lilyana Angelov; John H Suh; Toufik Djemil; Anthony Magnelli; Peng Qi; Tingliang Zhuang; Andrew Godley; Samuel T Chao Journal: Technol Cancer Res Treat Date: 2016-04-12
Authors: Maha Saada Jawad; Jun Zhou; Joe G Harb; J Ben Wilkinson; Shannon K Prausa; Jennifer Wloch; Daniel J Krauss; Daniel Fahim; Di Yan; Inga S Grills Journal: J Radiosurg SBRT Date: 2015