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Randomized Controlled Trial
Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.
- Séverine Racadot, Mariette Mercier, Sophie Dussart, Bernadette Dessard-Diana, René-Jean Bensadoun, Michel Martin, Emmanuelle Malaurie, Véronique Favrel, Martin Housset, Catherine Durdux, Catherine Journel, Gilles Calais, Jocelyne Huet, Gérard Pillet, Christophe Hennequin, Elias Haddad, Christian Diana, Brigitte Blaska-Jaulerry, Michel Henry-Amar, Pierre Géhanno, François Baillet, and Jean-Jacques Mazeron.
- Centre Léon Bérard, Department of Radiation Oncology, Lyon, France. racadot@lyon.fnclcc.fr
- Radiother Oncol. 2008 May 1; 87 (2): 164-72.
Background And PurposePost-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.Materials And MethodsThe study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly).ResultsBetween February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81).ConclusionsTwice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.
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