title: Radiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial.
abstract: Chemoradiation (RT-CT) is standard treatment for locally advanced cervical cancer (LACC). This study tried to establish if radiotherapy combined with hyperthermia (RT-HT) should be preferred in bulky and/or FIGO-stage ⩾III.
  
  
  
  In this open-label, multicenter randomized trial, patients with LACC were randomly assigned by a computer-generated, biased coin minimization technique to RT-CT or RT-HT. Central randomization was done with stratification by FIGO-stage, tumour diameter and nodal status. Primary endpoint was event free survival (EFS). Secondary endpoints were pelvic recurrence free survival (PRFS), overall survival (OS) and treatment related toxicity. Analysis was done by intention to treat.
  
  
  
  The trial was closed prematurely (87 of 376 planned patients enrolled: 43 RT-CT; 44 RT-HT). Median follow-up time was 7.1 years. The cumulative incidence of an event was 33% in the RT-CT group and 35% in the RT-HT group. The corresponding hazard rate (HR) for EFS was 1.15 (CI: 0.56-2.36, p=0.7). Also the hazards for PRFS (0.94; CI 0.36-2.44) and OS (1.04; CI 0.48-2.23) at 5 years were comparable between both treatment arms as was grade ⩾3 radiation related late toxicity (6 RT-CT and 5 RT-HT patients).
  
  
  
  After 25% of intended accrual, data suggest comparable outcome for RT-CT and RT-HT.
authors.affiliation: Maastricht Radiation Oncology (MAASTRO) Clinic, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands. Electronic address: ludy.lutgens@maastro.nl.
authors.forename: Ludy C H W
authors.initials: LC
authors.lastname: Lutgens
authors.affiliation: Department of Radiotherapy, Medical Center Haaglanden, The Hague, The Netherlands.
authors.forename: Peter C M
authors.initials: PC
authors.lastname: Koper
authors.affiliation: Department of Radiotherapy, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Jobsen
authors.affiliation: Radiotherapiegroep, Arnhem, The Netherlands.
authors.forename: Elzbieta M
authors.initials: EM
authors.lastname: van der Steen-Banasik
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Center, The Netherlands.
authors.forename: Carien L
authors.initials: CL
authors.lastname: Creutzberg
authors.affiliation: Department of Radiotherapy, Catharina Hospital Eindhoven, The Netherlands.
authors.forename: Hetty A
authors.initials: HA
authors.lastname: van den Berg
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Petronella B
authors.initials: PB
authors.lastname: Ottevanger
authors.affiliation: Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands; Department of Hyperthermia, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Gerard C
authors.initials: GC
authors.lastname: van Rhoon
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Helena C
authors.initials: HC
authors.lastname: van Doorn
authors.affiliation: Maastricht Radiation Oncology (MAASTRO) Clinic, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.
authors.forename: Ruud
authors.initials: R
authors.lastname: Houben
authors.affiliation: Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands; Department of Hyperthermia, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Jacoba
authors.initials: J
authors.lastname: van der Zee
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001918:Brachytherapy; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D015994:Incidence; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: Cervical cancer; Concurrent chemoradiation; Regional hyperthermia