title: Radiotherapy quality assurance review for a multi-center randomized trial of locally advanced esophageal cancer: the Japan Clinical Oncology Group (JCOG) trial 0303.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the radiotherapy (RT) quality assurance (QA) for JCOG 0303.
  
  
  METHODS
  JCOG 0303 was a multi-center phase II/III trial that compared two types of chemotherapy administered concomitantly with RT for locally advanced esophageal cancer. RT requirements included a total dose of 60 Gy in 30 fractions and CTV with a 2-cm margin cranio-caudally to the primary tumor. The QA assessment was given as per protocol (PP), deviation acceptable (DA), violation unacceptable (VU), and incomplete/not evaluable following predefined criteria for quality parameters.
  
  
  RESULTS
  A total of 142 cases were accrued. After excluding 36 incomplete/not evaluable, 106 (75%) were fully evaluable for RT quality review. Of these 106, there were 4 VU (4%) and overall RT compliance (PP + DA) was 96%. Comparing the incidence of VU based on the numbers enrolled by institution, the highest quarter of enrollment (≥7 cases) had no VU, while all VU (4; 11%) were from institutions enrolling <7 patients.
  
  
  CONCLUSIONS
  The results of the RTQA assessment for JCOG 0303 were sufficient to provide reliable results. Additional improvements will be needed for institutions with low accrual rates.
authors.affiliation: Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Sanuki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Masayuki
authors.initials: M
authors.lastname: Shinoda
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.forename: Nobutoshi
authors.initials: N
authors.lastname: Ando
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000473:pathology* / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011786:Quality Control; D011879:Radiotherapy Dosage / Q000592:standards*