Ludy C H W Lutgens1, Peter C M Koper2, Jan J Jobsen3, Elzbieta M van der Steen-Banasik4, Carien L Creutzberg5, Hetty A van den Berg6, Petronella B Ottevanger7, Gerard C van Rhoon8, Helena C van Doorn9, Ruud Houben10, Jacoba van der Zee8. 1. Maastricht Radiation Oncology (MAASTRO) Clinic, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands. Electronic address: ludy.lutgens@maastro.nl. 2. Department of Radiotherapy, Medical Center Haaglanden, The Hague, The Netherlands. 3. Department of Radiotherapy, Medisch Spectrum Twente, Enschede, The Netherlands. 4. Radiotherapiegroep, Arnhem, The Netherlands. 5. Department of Clinical Oncology, Leiden University Medical Center, The Netherlands. 6. Department of Radiotherapy, Catharina Hospital Eindhoven, The Netherlands. 7. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. 8. Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands; Department of Hyperthermia, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. 9. Department of Obstetrics and Gynecology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. 10. Maastricht Radiation Oncology (MAASTRO) Clinic, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.
Abstract
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.
RCT Entities:
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.
Authors: Marloes IJff; Gregor G W van Bochove; Denise Whitton; Roy Winiarczyk; Celina Honhoff; Hans Rodermond; Johannes Crezee; Lukas J A Stalpers; Nicolaas A P Franken; Arlene L Oei Journal: Cancers (Basel) Date: 2021-04-26 Impact factor: 6.639
Authors: Caspar M van Leeuwen; Arlene L Oei; Kenneth W T K Chin; Johannes Crezee; Arjan Bel; Anneke M Westermann; Marrije R Buist; Nicolaas A P Franken; Lukas J A Stalpers; H Petra Kok Journal: Radiat Oncol Date: 2017-04-27 Impact factor: 3.481
Authors: Marloes IJff; Bregje van Oorschot; Arlene L Oei; Przemek M Krawczyk; Hans M Rodermond; Lukas J A Stalpers; H Petra Kok; Johannes Crezee; Nicolaas A P Franken Journal: Int J Mol Sci Date: 2018-08-16 Impact factor: 5.923
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