title: Radiotherapy quality assurance of the Japanese Gynecologic Oncology Group study (JGOG1066): a cooperative phase II study of concurrent chemoradiotherapy for uterine cervical cancer.
abstract: BACKGROUND
  To assess radiotherapy protocol compliance in a multi-institutional phase II study of concurrent chemoradiotherapy for patients with locally advanced cancer of the uterine cervix (JGOG1066).
  
  
  METHODS
  For study protocol development, various radiotherapy parameters were examined and consensus was reached by Japanese radiation oncologists with cervical cancer treatment expertise. Quality assurance (QA) was also discussed and included in the protocol. A credentialing process was used to select institutions for participation in the study. Individual case reviews referring to 18 QA items were undertaken for each patient. Radiotherapy data were submitted to the Japanese Gynecologic Oncology Group (JGOG) data center and reviewed by the members of the radiotherapy committee. The QA evaluation was classed as per protocol, deviation, and violation.
  
  
  RESULTS
  Individual case reviews were performed on 69 of 72 patients entered in the study. In 24 patients (35%), there were no deviations for any QA items. There were also no deviations seen for 5 of the 18 items in 69 patients evaluated. Deviations of 64 QA items were seen in 45 cases, and violations were seen in 4 cases (4 items). The most common deviation concerned appropriate application for the external beam radiotherapy (EBRT) boost to involved nodes or parametrium (32 cases). The 4 violations were identified in the QA items regarding high-dose rate intracavitary brachytherapy.
  
  
  CONCLUSIONS
  Radiotherapy protocol compliance was favorable except for the EBRT boost indications. The results of this study validate the quality of radiotherapy in JGOG1066, and indicate that the final analysis will provide meaningful results.
authors.affiliation: Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, 207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan. b983255@med.u-ryukyu.ac.jp
authors.forename: Takafumi
authors.initials: T
authors.lastname: Toita
authors.forename: Shingo
authors.initials: S
authors.lastname: Kato
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Kayoko
authors.initials: K
authors.lastname: Tsujino
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kodaira
authors.forename: Takashi
authors.initials: T
authors.lastname: Uno
authors.forename: Kazuo
authors.initials: K
authors.lastname: Hatano
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Niibe
authors.forename: Tomoko
authors.initials: T
authors.lastname: Kazumoto
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nishimura
authors.forename: Ryo
authors.initials: R
authors.lastname: Kitagawa
authors.forename: Miki
authors.initials: M
authors.lastname: Fukutani
authors.forename: Masahiko
authors.initials: M
authors.lastname: Oguchi
authors.forename: Kenji
authors.initials: K
authors.lastname: Umayahara
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Hirashima
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Aoki
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D000368:Aged; D024221:Antineoplastic Protocols / Q000592:standards; D059248:Chemoradiotherapy / Q000592:standards*; D017322:Clinical Trials, Phase II as Topic; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011785:Quality Assurance, Health Care; D011786:Quality Control; D011879:Radiotherapy Dosage / Q000592:standards; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000628:therapy*