A randomized phase 2 study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage i peripheral non-small cell lung cancer: NRG Oncology RTOG 0915 (NCCTG N0927)

Gregory M M Videtic, Chen Hu, Anurag K. Singh, Joe Y. Chang, William Parker, Kenneth R. Olivier, Steven E. Schild, Ritsuko Komaki, James J. Urbanic, Hak Choy

Research output: Contribution to journalArticle

Abstract

Purpose: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade 3 protocol-specified adverse events (psAEs) at 1 year. Methods and Materials: Patients with biopsy-proven peripheral (2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2). Rigorous central accreditation and quality assurance confirmed treatment per protocol guidelines. This study was designed to detect a psAEs rate >17% at a 10% significance level (1-sided) and 90% power. Secondary endpoints included rates of primary tumor control (PC), overall survival (OS), and disease-free survival (DFS) at 1 year. Designating the better of the 2 regimens was based on prespecified rules of psAEs and PC for each arm. Results: Ninety-four patients were accrued between September 2009 and March 2011. The median follow-up time was 30.2 months. Of 84 analyzable patients, 39 were in arm 1 and 45 in arm 2. Patient and tumor characteristics were balanced between arms. Four (10.3%) patients on arm 1 (95% confidence interval [CI] 2.9%-24.2%) and 6 (13.3%) patients on arm 2 (95% CI 5.1%-26.8%) experienced psAEs. The 2-year OS rate was 61.3% (95% CI 44.2%-74.6%) for arm 1 patients and 77.7% (95% CI 62.5%-87.3%) for arm 2. The 2-year DFS was 56.4% (95% CI 39.6%-70.2%) for arm 1 and 71.1% (95% CI 55.5%-82.1%) for arm 2. The 1-year PC rate was 97.0% (95% CI 84.2%-99.9%) for arm 1 and 92.7% (95% CI 80.1%-98.5%) for arm 2. Conclusions: 34 Gy in 1 fraction met the prespecified criteria and, of the 2 schedules, warrants further clinical research.

Original languageEnglish (US)
Pages (from-to)757-764
Number of pages8
JournalInternational Journal of Radiation Oncology, Biology, Physics
Volume93
Issue number4
DOIs
StatePublished - 2015

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schedules
Non-Small Cell Lung Carcinoma
lungs
confidence
radiation therapy
Appointments and Schedules
Radiotherapy
cancer
Confidence Intervals
intervals
tumors
Neoplasms
Disease-Free Survival
Accreditation
assurance
Clinical Protocols
Positron-Emission Tomography
grade
positrons
Lung Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

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A randomized phase 2 study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage i peripheral non-small cell lung cancer : NRG Oncology RTOG 0915 (NCCTG N0927). / Videtic, Gregory M M; Hu, Chen; Singh, Anurag K.; Chang, Joe Y.; Parker, William; Olivier, Kenneth R.; Schild, Steven E.; Komaki, Ritsuko; Urbanic, James J.; Choy, Hak.

In: International Journal of Radiation Oncology, Biology, Physics, Vol. 93, No. 4, 2015, p. 757-764.

Research output: Contribution to journalArticle

Videtic, Gregory M M ; Hu, Chen ; Singh, Anurag K. ; Chang, Joe Y. ; Parker, William ; Olivier, Kenneth R. ; Schild, Steven E. ; Komaki, Ritsuko ; Urbanic, James J. ; Choy, Hak. / A randomized phase 2 study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage i peripheral non-small cell lung cancer : NRG Oncology RTOG 0915 (NCCTG N0927). In: International Journal of Radiation Oncology, Biology, Physics. 2015 ; Vol. 93, No. 4. pp. 757-764.
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title = "A randomized phase 2 study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage i peripheral non-small cell lung cancer: NRG Oncology RTOG 0915 (NCCTG N0927)",
abstract = "Purpose: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade 3 protocol-specified adverse events (psAEs) at 1 year. Methods and Materials: Patients with biopsy-proven peripheral (2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2). Rigorous central accreditation and quality assurance confirmed treatment per protocol guidelines. This study was designed to detect a psAEs rate >17{\%} at a 10{\%} significance level (1-sided) and 90{\%} power. Secondary endpoints included rates of primary tumor control (PC), overall survival (OS), and disease-free survival (DFS) at 1 year. Designating the better of the 2 regimens was based on prespecified rules of psAEs and PC for each arm. Results: Ninety-four patients were accrued between September 2009 and March 2011. The median follow-up time was 30.2 months. Of 84 analyzable patients, 39 were in arm 1 and 45 in arm 2. Patient and tumor characteristics were balanced between arms. Four (10.3{\%}) patients on arm 1 (95{\%} confidence interval [CI] 2.9{\%}-24.2{\%}) and 6 (13.3{\%}) patients on arm 2 (95{\%} CI 5.1{\%}-26.8{\%}) experienced psAEs. The 2-year OS rate was 61.3{\%} (95{\%} CI 44.2{\%}-74.6{\%}) for arm 1 patients and 77.7{\%} (95{\%} CI 62.5{\%}-87.3{\%}) for arm 2. The 2-year DFS was 56.4{\%} (95{\%} CI 39.6{\%}-70.2{\%}) for arm 1 and 71.1{\%} (95{\%} CI 55.5{\%}-82.1{\%}) for arm 2. The 1-year PC rate was 97.0{\%} (95{\%} CI 84.2{\%}-99.9{\%}) for arm 1 and 92.7{\%} (95{\%} CI 80.1{\%}-98.5{\%}) for arm 2. Conclusions: 34 Gy in 1 fraction met the prespecified criteria and, of the 2 schedules, warrants further clinical research.",
author = "Videtic, {Gregory M M} and Chen Hu and Singh, {Anurag K.} and Chang, {Joe Y.} and William Parker and Olivier, {Kenneth R.} and Schild, {Steven E.} and Ritsuko Komaki and Urbanic, {James J.} and Hak Choy",
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T1 - A randomized phase 2 study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage i peripheral non-small cell lung cancer

T2 - NRG Oncology RTOG 0915 (NCCTG N0927)

AU - Videtic, Gregory M M

AU - Hu, Chen

AU - Singh, Anurag K.

AU - Chang, Joe Y.

AU - Parker, William

AU - Olivier, Kenneth R.

AU - Schild, Steven E.

AU - Komaki, Ritsuko

AU - Urbanic, James J.

AU - Choy, Hak

PY - 2015

Y1 - 2015

N2 - Purpose: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade 3 protocol-specified adverse events (psAEs) at 1 year. Methods and Materials: Patients with biopsy-proven peripheral (2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2). Rigorous central accreditation and quality assurance confirmed treatment per protocol guidelines. This study was designed to detect a psAEs rate >17% at a 10% significance level (1-sided) and 90% power. Secondary endpoints included rates of primary tumor control (PC), overall survival (OS), and disease-free survival (DFS) at 1 year. Designating the better of the 2 regimens was based on prespecified rules of psAEs and PC for each arm. Results: Ninety-four patients were accrued between September 2009 and March 2011. The median follow-up time was 30.2 months. Of 84 analyzable patients, 39 were in arm 1 and 45 in arm 2. Patient and tumor characteristics were balanced between arms. Four (10.3%) patients on arm 1 (95% confidence interval [CI] 2.9%-24.2%) and 6 (13.3%) patients on arm 2 (95% CI 5.1%-26.8%) experienced psAEs. The 2-year OS rate was 61.3% (95% CI 44.2%-74.6%) for arm 1 patients and 77.7% (95% CI 62.5%-87.3%) for arm 2. The 2-year DFS was 56.4% (95% CI 39.6%-70.2%) for arm 1 and 71.1% (95% CI 55.5%-82.1%) for arm 2. The 1-year PC rate was 97.0% (95% CI 84.2%-99.9%) for arm 1 and 92.7% (95% CI 80.1%-98.5%) for arm 2. Conclusions: 34 Gy in 1 fraction met the prespecified criteria and, of the 2 schedules, warrants further clinical research.

AB - Purpose: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade 3 protocol-specified adverse events (psAEs) at 1 year. Methods and Materials: Patients with biopsy-proven peripheral (2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2). Rigorous central accreditation and quality assurance confirmed treatment per protocol guidelines. This study was designed to detect a psAEs rate >17% at a 10% significance level (1-sided) and 90% power. Secondary endpoints included rates of primary tumor control (PC), overall survival (OS), and disease-free survival (DFS) at 1 year. Designating the better of the 2 regimens was based on prespecified rules of psAEs and PC for each arm. Results: Ninety-four patients were accrued between September 2009 and March 2011. The median follow-up time was 30.2 months. Of 84 analyzable patients, 39 were in arm 1 and 45 in arm 2. Patient and tumor characteristics were balanced between arms. Four (10.3%) patients on arm 1 (95% confidence interval [CI] 2.9%-24.2%) and 6 (13.3%) patients on arm 2 (95% CI 5.1%-26.8%) experienced psAEs. The 2-year OS rate was 61.3% (95% CI 44.2%-74.6%) for arm 1 patients and 77.7% (95% CI 62.5%-87.3%) for arm 2. The 2-year DFS was 56.4% (95% CI 39.6%-70.2%) for arm 1 and 71.1% (95% CI 55.5%-82.1%) for arm 2. The 1-year PC rate was 97.0% (95% CI 84.2%-99.9%) for arm 1 and 92.7% (95% CI 80.1%-98.5%) for arm 2. Conclusions: 34 Gy in 1 fraction met the prespecified criteria and, of the 2 schedules, warrants further clinical research.

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