title: Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV<100 cc using a continual reassessment method (JCOG0702).
abstract: OBJECTIVE
  To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc.
  
  
  METHODS
  The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV.
  
  
  RESULTS
  Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions.
  
  
  CONCLUSIONS
  The RD of SBRT for peripheral T2N0M0 NSCLC with PTV<100 cc was determined to be 55 Gy in 4 fractions.
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 Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shirato
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, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hiraoka
authors.affiliation: Department of Radiology, Koshigaya Municipal Hospital, 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, 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 Radiology, University of Yamanashi Graduate School of Medical Science, Chuo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Onishi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000601:surgery*; D008297:Male; D020714:Maximum Tolerated Dose; D009367:Neoplasm Staging; D016634:Radiosurgery / Q000009:adverse effects; D011879:Radiotherapy Dosage
keywords: Continual reassessment method; Non-small cell lung cancer (NSCLC); Phase I study; SBRT; Stereotactic body radiotherapy