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) [Description of the GORTEC 2017-03 study: Postoperative stereotactic radiotherapy for early stage oropharyngeal and oral cavity cancer with high risk margin (PHRC-K-16-164)]
Details
Serval ID
serval:BIB_418118EBB774
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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) [Description of the GORTEC 2017-03 study: Postoperative stereotactic radiotherapy for early stage oropharyngeal and oral cavity cancer with high risk margin (PHRC-K-16-164)]
Journal
Cancer radiotherapie
ISSN
1769-6658 (Electronic)
ISSN-L
1278-3218
Publication state
Published
Issued date
10/2017
Peer-reviewed
Oui
Volume
21
Number
6-7
Pages
527-532
Language
french
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study
Publication Status: ppublish
Publication Status: ppublish
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.
Keywords
Combined Modality Therapy, Humans, Margins of Excision, Mouth Neoplasms/pathology, Mouth Neoplasms/radiotherapy, Mouth Neoplasms/surgery, Neoplasm Staging, Oropharyngeal Neoplasms/pathology, Oropharyngeal Neoplasms/radiotherapy, Oropharyngeal Neoplasms/surgery, Postoperative Care, Radiosurgery, Research Design, Risk Assessment, Cancers tête et cou localisés, Early stage head and neck carcinoma, Postoperative, Postopératoire, Radiothérapie stéréotaxique, Stereotactic radiotherapy
Pubmed
Web of science
Create date
22/09/2017 12:40
Last modification date
20/08/2019 13:42