title: Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403.
abstract: OBJECTIVE
  To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients.
  
  
  RESULTS
  Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed.
  
  
  CONCLUSIONS
  Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.
authors.affiliation: Department of Radiation Oncology, Hiroshima University, Hiroshima, Japan. Electronic address: nagat@hiroshima-u.ac.jp.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Nagata
authors.affiliation: Department of Radiation Oncology and Image-Applied Therapy, Kyoto University, Kyoto, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hiraoka
authors.affiliation: Japan Clinical Oncology Group Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Radiology, University of Yamanashi, Chuo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Onishi
authors.affiliation: Department of Image-Based Medicine, Institute of Biomedical Research and Innovation, Kobe, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Kokubo
authors.affiliation: Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Karasawa
authors.affiliation: Department of Clinical Radiology, Kyushu University, Fukuoka, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Shioyama
authors.affiliation: Department of Radiology, Hokkaido University, Sapporo, Japan.
authors.forename: Rikiya
authors.initials: R
authors.lastname: Onimaru
authors.affiliation: Department of Radiation Oncology, The Cancer Institute Hospital, Tokyo, Japan.
authors.forename: Takuyo
authors.initials: T
authors.lastname: Kozuka
authors.affiliation: Department of Radiation Oncology, Keio University, Tokyo, Japan.
authors.forename: Etsuo
authors.initials: E
authors.lastname: Kunieda
authors.affiliation: Department of Radiology, Nihon University Itabashi Hospital, Tokyo, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Saito
authors.affiliation: Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Nakagawa
authors.affiliation: Department of Radiology, Sapporo Medical University, Sapporo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Hareyama
authors.affiliation: Department of Radiation Oncology, Tohoku University, Sendai, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Takai
authors.affiliation: Department of Radiology and Radiation Oncology, Kitasato University, Sagamihara, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.affiliation: Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Mitsuhashi
authors.affiliation: Department of Radiology, Koshigaya Municipal Hospital, Koshigaya, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016001:Confidence Intervals; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016634:Radiosurgery / Q000009:adverse effects / Q000379:methods* / Q000401:mortality