Radiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial

LCHW Lutgens, PCM Koper, JJ Jobsen, EM van de Steen-Banasik, CL Creutzberg, HA van den Berg, PB Ottevanger, Gerard van Rhoon, Lena van Doorn, R Houben, Cobi Zee

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Background: 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. Methods: 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. Results: 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). Conclusion: After 25% of intended accrual, data suggest comparable outcome for RT-CT and RT-HT. (C) 2016 Elsevier Ireland Ltd. All rights reserved.
Original languageUndefined/Unknown
Pages (from-to)378-382
Number of pages5
JournalRadiotherapy and Oncology
Issue number3
Publication statusPublished - 2016

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