title: A prospective nonrandomized phase I/II study of carbon ion radiotherapy in a favorable subset of locally advanced non-small cell lung cancer (NSCLC).
abstract: BACKGROUND
  Although concurrent chemoradiotherapy (CCRT) has become the standard approach for unresectable locally advanced non-small cell lung cancer (LA-NSCLC), most patients are not candidates for this treatment because of comorbidities. We evaluated the safety and efficacy of carbon ion radiotherapy (CIRT) in LA-NSCLC patients.
  
  
  METHODS
  Patients with stage IIA to IIIA (UICC 7th edition) LA-NSCLC were enrolled in a sequential phase I/II trial. For a phase I dose escalation study, the total prescribed dose was increased by 4 Gray equivalents (GyE) in 2 steps, from 68 to 72 GyE and then to 76 GyE, using 16 fractions over 4 weeks. After determining the recommended dose, the phase II trial was started in an expanded cohort.
  
  
  RESULTS
  Of the 36 patients treated in phase I, 2 grade 3 adverse events (radiation pneumonitis and tracheoesophageal fistula) were observed in the 76 GyE group. Accordingly, for phase II, the next consecutive 26 patients were treated with 72 GyE, with no grade 3 to 5 toxicities resulting. A total of 62 eligible patients were recruited. The majority of patients (49 of 62) were N0 or N1 patients, and the rest (13 of 62) were single-station N2 patients. The median follow-up period was 25.2 months. The 2-year local control rate (LCR) and overall survival (OS) for the entire cohort were 93.1% and 51.9%, respectively. In particular, patients with cT3-4N0 had an excellent prognosis; the 2-year OS and LCR were 69.3% and 100%, respectively.
  
  
  CONCLUSIONS
  Short-course CIRT monotherapy shows promise as an effective nonsurgical treatment for inoperable LA-NSCLC.
authors: Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan; Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan.
authors: Wataru
authors: W
authors: Takahashi
authors: Mio
authors: M
authors: Nakajima
authors: Naoyoshi
authors: N
authors: Yamamoto
authors: Hideomi
authors: H
authors: Yamashita
authors: Keiichi
authors: K
authors: Nakagawa
authors: Tadaaki
authors: T
authors: Miyamoto
authors: Hiroshi
authors: H
authors: Tsuji
authors: Tadashi
authors: T
authors: Kamada
authors: Takehiko
authors: T
authors: Fujisawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002244:Carbon / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D063193:Heavy Ion Radiotherapy / Q000009:adverse effects*; D020450:Heavy Ions / Q000009:adverse effects*; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002244:Carbon
keywords: carbon ion Radiotherapy/TO; carbon ion radiotherapy/MT; clinical trial; non-small cell lung cancer; phase 1; phase 2; treatment effectiveness