title: Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer (JCOG0702): Results for the group with PTV⩾100cc.
abstract: A dose escalation study to determine the recommended dose (RD) with stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinomas (NSCLC) was conducted. The results of the group with PTV⩾100cc are reported in this paper.
  
  
  
  The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) was Grade 3 or higher radiation pneumonitis (RP), and Grade 2 or higher RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95of the PTV.
  
  
  
  Thirteen patients were accrued. More patients should have been enrolled but we decided not to prolong the study period. No patients experienced Grade 3 RP. Two patients experienced Grade 2 RP at 50Gy in 4 fractions. The predicted MTD was 50.2Gy. The posterior probability of the Grade 2 RP frequency over 40% was 5.3% for the dose level of 50Gy. The RD was determined to be 50Gy.
  
  
  
  The RD was determined to be 50Gy in 4 fractions in this population.
authors.affiliation: Department of Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan. Electronic address: ronimaru@pop.med.hokudai.ac.jp.
authors.forename: Rikiya
authors.initials: R
authors.lastname: Onimaru
authors.affiliation: Department of Radiology, University of Yamanashi Graduate School of Medical Science, Chuo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Onishi
authors.affiliation: JCOG 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 Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hiraoka
authors.affiliation: Department of Radiology, Koshigaya Municipal Hospital, Koshigaya, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.affiliation: Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Karasawa
authors.affiliation: Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Matsuo
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 Clinical Radiology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Shioyama
authors.affiliation: Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Haruo
authors.initials: H
authors.lastname: Matsushita
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shirato
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D017564:Radiation Pneumonitis / Q000209:etiology; D016634:Radiosurgery; D011879:Radiotherapy Dosage; D047368:Tumor Burden
keywords: Continual reassessment method; Dose escalation study; Non-small cell lung cancer (NSCLC); Stereotactic body radiotherapy (SBRT)