title: Radiotherapy quality assurance review in a multi-center randomized trial of limited-disease small cell lung cancer: the Japan Clinical Oncology Group (JCOG) trial 0202.
abstract: BACKGROUND
  The purpose of this study was to analyze the radiotherapy (RT) quality assurance (QA) assessment in Japan Clinical Oncology Group (JCOG) 0202, which was the first trial that required on-going RT QA review in the JCOG.
  
  
  METHODS
  JCOG 0202 was a multi-center phase III trial comparing two types of consolidation chemotherapy after concurrent chemoradiotherapy for limited-disease small cell lung cancer. RT requirements included a total dose of 45 Gy/30 fx (bis in die, BID/twice a day) without heterogeneity correction; elective nodal irradiation (ENI) of 30 Gy; at least 1 cm margin around the clinical target volume (CTV); and interfraction interval of 6 hours or longer. Dose constraints were defined in regards to the spinal cord and the lung. The QA assessment was classed as per protocol (PP), deviation acceptable (DA), violation unacceptable (VU), and incomplete/not evaluable (I/NE).
  
  
  RESULTS
  A total of 283 cases were accrued, of which 204 were fully evaluable, excluding 79 I/NE cases. There were 18 VU in gross tumor volume (GTV) coverage (8% of 238 evaluated); 4 VU and 23 DA in elective nodal irradiation (ENI) (2% and 9% of 243 evaluated, respectively). Some VU were observed in organs at risk (1 VU in the lung and 5 VU in the spinal cord). Overall RT compliance (PP + DA) was 92% (187 of 204 fully evaluable). Comparison between the former and latter halves of the accrued cases revealed that the number of VU and DA had decreased.
  
  
  CONCLUSIONS
  The results of the RT QA assessment in JCOG 0202 seemed to be acceptable, providing reliable results.
authors.affiliation: Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan. nao5-tky@umin.ac.jp
authors.forename: Naoko
authors.initials: N
authors.lastname: Sanuki-Fujimoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011878:Radiotherapy / Q000592:standards*; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy / Q000532:radiotherapy*