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: OBJECTIVE
  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
  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.
authors.affiliation: The Cleveland Clinic, Cleveland, Ohio. Electronic address: videtig@ccf.org.
authors.forename: Gregory M M
authors.initials: GM
authors.lastname: Videtic
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania; Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Chen
authors.initials: C
authors.lastname: Hu
authors.affiliation: Roswell Park Cancer Institute, Buffalo, New York.
authors.forename: Anurag K
authors.initials: AK
authors.lastname: Singh
authors.affiliation: MD Anderson Cancer Center, Houston, Texas.
authors.forename: Joe Y
authors.initials: JY
authors.lastname: Chang
authors.affiliation: McGill University Health Center, Montreal, Québec, Canada.
authors.forename: William
authors.initials: W
authors.lastname: Parker
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Olivier
authors.affiliation: Mayo Clinic, Scottsdale, Arizona.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.affiliation: MD Anderson Cancer Center, Houston, Texas.
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Komaki
authors.affiliation: Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: James J
authors.initials: JJ
authors.lastname: Urbanic
authors.forename: Robert D
authors.initials: RD
authors.lastname: Timmerman
authors.affiliation: The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas.
authors.forename: Hak
authors.initials: H
authors.lastname: Choy
mesh_terms: D000068:Accreditation; D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D002423:Cause of Death; D016001:Confidence Intervals; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D056888:Patient Positioning; D016634:Radiosurgery / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D015996:Survival Rate; D013997:Time Factors