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

80 Citations (Scopus)

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 2014

Fingerprint

Radiation Oncology
Radiosurgery
Spine
Radiotherapy
Neoplasm Metastasis
Spinal Cord
Pain
Compliance
Guideline Adherence
National Cancer Institute (U.S.)
Quality Control
Prescriptions
Thorax
Quality of Life
Safety

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases : Phase 2 results. / Ryu, Samuel; Pugh, Stephanie L.; Gerszten, Peter C.; Yin, Fang Fang; Timmerman, Robert D.; Hitchcock, Ying J.; Movsas, Benjamin; Kanner, Andrew A.; Berk, Lawrence B.; Followill, David S.; Kachnic, Lisa A.

In: Practical Radiation Oncology, Vol. 4, No. 2, 03.2014, p. 76-81.

Research output: Contribution to journalArticle

Ryu, S, Pugh, SL, Gerszten, PC, Yin, FF, Timmerman, RD, Hitchcock, YJ, Movsas, B, Kanner, AA, Berk, LB, Followill, DS & Kachnic, LA 2014, 'RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: Phase 2 results', Practical Radiation Oncology, vol. 4, no. 2, pp. 76-81. https://doi.org/10.1016/j.prro.2013.05.001
Ryu, Samuel ; Pugh, Stephanie L. ; Gerszten, Peter C. ; Yin, Fang Fang ; Timmerman, Robert D. ; Hitchcock, Ying J. ; Movsas, Benjamin ; Kanner, Andrew A. ; Berk, Lawrence B. ; Followill, David S. ; Kachnic, Lisa A. / RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases : Phase 2 results. In: Practical Radiation Oncology. 2014 ; Vol. 4, No. 2. pp. 76-81.
@article{0ca7b3da65794dbb950aefa7284002d7,
title = "RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: Phase 2 results",
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.",
author = "Samuel Ryu and Pugh, {Stephanie L.} and Gerszten, {Peter C.} and Yin, {Fang Fang} and Timmerman, {Robert D.} and Hitchcock, {Ying J.} and Benjamin Movsas and Kanner, {Andrew A.} and Berk, {Lawrence B.} and Followill, {David S.} and Kachnic, {Lisa A.}",
year = "2014",
month = "3",
doi = "10.1016/j.prro.2013.05.001",
language = "English (US)",
volume = "4",
pages = "76--81",
journal = "Practical Radiation Oncology",
issn = "1879-8500",
publisher = "Elsevier BV",
number = "2",

}

TY - JOUR

T1 - RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases

T2 - Phase 2 results

AU - Ryu, Samuel

AU - Pugh, Stephanie L.

AU - Gerszten, Peter C.

AU - Yin, Fang Fang

AU - Timmerman, Robert D.

AU - Hitchcock, Ying J.

AU - Movsas, Benjamin

AU - Kanner, Andrew A.

AU - Berk, Lawrence B.

AU - Followill, David S.

AU - Kachnic, Lisa A.

PY - 2014/3

Y1 - 2014/3

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84896699065&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84896699065&partnerID=8YFLogxK

U2 - 10.1016/j.prro.2013.05.001

DO - 10.1016/j.prro.2013.05.001

M3 - Article

VL - 4

SP - 76

EP - 81

JO - Practical Radiation Oncology

JF - Practical Radiation Oncology

SN - 1879-8500

IS - 2

ER -