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Phase III Randomized Trial of Very Accelerated Radiation Therapy Compared With Conventional Radiation Therapy in Squamous Cell Head and Neck Cancer: A GORTEC Trial

Jean Bourhis, Michel Lapeyre, Jacques Tortochaux, Michel Rives, Mehdi Aghili, Sylvain Bourdin, François Lesaunier, Toufik Benassi, Claire Lemanski, Lionel Geoffrois, Antoine Lusinchi, Pierre Verrelle, Etienne Bardet, Morbize Julieron, Pierre Wibault, Monique Luboinski, Ellen Benhamou

From the Institut Gustave Roussy, Radiation Oncology, Head and Neck Statistics Departments, Villejuif; Centre Alexis Vautrin, Nancy; Centre Jean Perrin, Clermont-Ferrand; Centre Claudius Regaud, Toulouse; Centre René Gauducheau, Nantes; Centre Francois Baclesse, Caen; Centre Hospitalier, Lagny; and the Centre Val D'aurelle, Montpellier, France

Address reprint requests to Jean Bourhis, MD, PhD, Department of Radiation-Oncology, Gustave Roussy Institute, 39 rue Camille Desmoulins, 94805 Villejuif, France; e-mail: bourhis{at}igr.fr

PURPOSE: With the aim to increase the dose intensity of radiation therapy (RT), and subsequently the locoregional control rate, a very accelerated RT regimen was compared with conventional RT in a series of patients with head and neck squamous cell carcinoma (HNSCC).

PATIENTS AND METHODS: Between 1994 and 1998, 268 patients with T3 or T4, N0 to N3 HNSCC (staged by 1997 International Union Against Cancer criteria) that was not eligible for surgery were randomly assigned to receive either conventional RT, delivering 70 Gy in 7 weeks to the primary tumor and 35 fractions of 2 Gy over 49 days, or to receive very accelerated RT, delivering 62 to 64 Gy in 31 to 32 fractions of 2 Gy over 22 to 23 days (2 Gy/fraction bid).

RESULTS: The most common tumor site was the oropharynx and most of the patients (70%) had T4 and N1 to N3 tumors in 72% of patients. The main patient and tumor characteristics were well-balanced between the two arms. The median total doses were 63 Gy (accelerated) and 70 Gy (conventional), with a median overall time of 22 days and 48 days, respectively. Acute mucositis was markedly increased in the accelerated-RT arm (P < .001). The locoregional control rate was improved by 24% at 6 years with accelerated RT. In contrast, disease-free survival and overall survival were not significantly different between the two arms. There was no difference in late effects between the two arms.

CONCLUSION: The very accelerated RT regimen was feasible and provided a major benefit in locoregional control but had a modest effect on survival.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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