1. Présentation de l’étude Gortec 2017-03 : radiothérapie en conditions stéréotaxiques postopératoire des cancers localisés de l’oropharynx et de la cavité buccale avec marges à risque (PHRC-K-16-164)
- Author
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Julian Biau, J. Miroir, Nicolas Saroul, C. Millardet, Michel Lapeyre, J. H. Bourhis, B. Pereira, Florence Huguet, N. Pham-Dang, Fabrice Kwiatkowski, Séverine Racadot, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Centre Léon Bérard [Lyon], Laboratoire d'Hématologie [Purpan], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Cognition et Activités finalisées (CAF), Centre National de la Recherche Scientifique (CNRS)-Université Paris 8 Vincennes-Saint-Denis (UP8), CHU Clermont-Ferrand, Département de Radiothérapie, Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), and Service de Radiothérapie (CLERMONT FERRAND - Radiothérapie)
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Brachytherapy ,Population ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,medicine ,Radiology, Nuclear Medicine and imaging ,Stage (cooking) ,education ,ComputingMilieux_MISCELLANEOUS ,Gynecology ,Chemotherapy ,education.field_of_study ,business.industry ,Cancer ,medicine.disease ,3. Good health ,Radiation therapy ,Oncology ,030220 oncology & carcinogenesis ,Concomitant ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
The GORTEC 2017-03-Stereo-postop study is a phase 2, multicentric, nationwide study, funded by the hospital clinical research program (PHRC). The sponsor is Centre Jean-Perrin in Clermont-Ferrand, in partnership with the GORTEC. The principal investigators are Dr J Biau and Dr M Lapeyre. The main objective is to study severe late toxicity of postoperative stereotactic radiotherapy (6×6Gy) for early stage oropharyngeal and oral cavity cancer with high risk margins. The secondary objectives include acute toxicity, efficacy, nutritional impact and quality of life. The population is adult patients, with pT1 or pT2 squamous cell carcinoma of the oropharynx or oral cavity (except lips), without indication of neck irradiation or concomitant chemotherapy, with at risk margin (R1, less than 5mm or uncertain). Ninety patients will be included over a 2-year period; this was calculated to limit the rate of 2-year severe toxicity at 5 to 15%, with a 2-year local control of at least 80 to 90%. If this study is considered as positive, stereotactic radiotherapy (6×6Gy) could become the third therapeutic option, with brachytherapy and normofractionated intensity-modulated radiotherapy (IMRT), for postoperative irradiation of oropharyngeal and oral cavity cancer with high risk margins.
- Published
- 2017
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