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Cancer Radiother. 2017 Oct;21(6-7):527-532. doi: 10.1016/j.canrad.2017.07.033. Epub 2017 Aug 31.

[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)].

[Article in French]

Author information

1
Département de radiothérapie, centre Jean-Perrin, 58, rue Montalembert, 63011 Clermont-Ferrand, France. Electronic address: Julian.biau@clermont.unicancer.fr.
2
Département de radiothérapie, centre Jean-Perrin, 58, rue Montalembert, 63011 Clermont-Ferrand, France.
3
Département de physique médicale, centre Jean-Perrin, 58, rue Montalembert, 63011 Clermont-Ferrand, France.
4
Département d'ORL-CCF, CHU Gabriel-Montpied, 58, rue Montalembert, 63011 Clermont-Ferrand, France.
5
Département de chirurgie maxillo-faciale, CHU Estaing, 1, rue Lucie-Aubrac, 63100 Clermont-Ferrand, France.
6
Département de radiothérapie, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.
7
Département de radiothérapie, hôpital Tenon-AP-HP, 4, rue de la Chine, 75020 Paris, France.
8
Département de recherche clinique, centre Jean-Perrin, 58, rue Montalembert, 63011 Clermont-Ferrand, France.
9
Département de biostatistiques, DRCI, CHU Clermont-Ferrand, 63003 Clermont-Ferrand, France.
10
Département de radiothérapie, CHUV, 1011 Lausanne, Suisse.

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:

Cancers tête et cou localisés; Early stage head and neck carcinoma; Postoperative; Postopératoire; Radiothérapie stéréotaxique; Stereotactic radiotherapy

PMID:
28865970
DOI:
10.1016/j.canrad.2017.07.033
[Indexed for MEDLINE]

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