title: A multicentre randomised clinical trial of chemoradiotherapy plus hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer.
abstract: To evaluate the effectiveness of whole-pelvic hyperthermia (HT) added to standard chemoradiotherapy (CRT) in locally advanced cervical cancer (CC), by investigating the clinical response and survival of patients treated with cisplatin-based CRT vs. CRT with HT (CRT + HT).
  
  
  
  This study was conducted at five hospitals in Japan between September 2001 and March 2015 in patients with the International Federation of Gynecology and Obstetrics stage IB (bulky)-IVA CC undergoing definitive CRT. After giving a written informed consent, patients were randomly allocated to two treatment groups: CRT and CRT + HT group. Overall survival (OS), disease-free survival (DFS), local relapse-free survival (LRFS), complete response (CR) rate and tolerability were evaluated.
  
  
  
  In total, 101 patients were treated. Patient characteristics, total dose of cisplatin and radiotherapy were similar for both groups. Although not statistically significant, the 5-year OS, DFS and LRFS in the CRT + HT group (77.8%, 70.8% and 80.1%, respectively) were better than those in the CRT group (64.8%, 60.6% and 71.0%, respectively). CR was significantly more likely to be achieved in patients in the CRT + HT group than in the CRT group (88% vs. 77.6%; adjusted odds ratio, 3.993; 95% confidence interval, 1.018-15.67; p = .047). CRT + HT was well tolerated and caused no additional acute or long-term toxicity compared with CRT alone.
  
  
  
  HT combined with CRT improved the CR rate of CRT in patients with locally advanced CC, however, could not improve survival outcomes. Further studies in larger samples are warranted.
authors.affiliation: a Department of Radiology , Kansai Medical University , Moriguchi City , Japan ;
authors.forename: Yoko
authors.initials: Y
authors.lastname: Harima
authors.affiliation: b Department of Radiology , University of Occupational and Environmental Health , Kitakyusyu City , Japan ;
authors.forename: Takayuki
authors.initials: T
authors.lastname: Ohguri
authors.affiliation: c Cancer Therapy Center, Tobata Kyoritsu Hospital , Kitakyusyu City , Japan ;
authors.forename: Hajime
authors.initials: H
authors.lastname: Imada
authors.affiliation: d Department of Radiation Oncology , University of Tsukuba , Tsukuba City , Japan ;
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
authors.affiliation: e Department of Radiation Oncology , Gunma University Heavy Ion Medical Center , Maehashi City , Japan ;
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ohno
authors.affiliation: f Department of Radiology , Kagoshima University , Kagoshima City , Japan ;
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Hiraki
authors.affiliation: g Department of Radiology , National Hospital Organization Minami Wakayama Medical Center , Tanabe City , Japan ;
authors.forename: Koh
authors.initials: K
authors.lastname: Tuji
authors.affiliation: h Department of Radiation Oncology , Osaka City General Hospital , Osaka City , Japan ;
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: i Department of Radiology , Harasanshin Hospital , Fukuoka City , Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Terashima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000628:therapy*; D055815:Young Adult
keywords: Cervical cancer; chemoradiotherapy; hyperthermia; randomisation