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Spots Global Cancer Trial Database for Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

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Trial Identification

Brief Title: Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02

Study ID: NCT01427478

Study Description

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.

Detailed Description: The reference treatment for operated squamous cell carcinoma of the head and the neck is a radiochemotherapy with Cisplatin (in the dose of intravenous 100 mg / m2 IV) every 3 weeks). The Receptor of EGFR (Epidermal Growth Factor) or REGF is a membrane receptor; it's activation leads the cellular growth and inhibits apoptotic capacities. This receptor is overexpressed in numerous solid tumors, including ENT tumors. Several clinical studies showed that an over expression of the REGF in ENT tumors was a dominant factor of poor prognostic. Afatinib (BIBW2992) is a strong and irreversible inhibitor of the EGFR ( type 1 human epidermic growth factor receptor, also known as HER1) and of the HER2 (human epidermal growth factor receptor 2). Currently, 3 phase III clinical studies in postoperative situation and using an anti-REGF are in progress: 2 in concomitant situation with the radiotherapy and 1 both in concomitance and in adjuvant therapy with radiotherapy. The preliminary results of a phase II study show that Afatinib is efficient in patients with local or metastatic relapse of a squamous cell carcinoma of the sphere ENT after a first line with Cisplatin and its tolerance is correct. These data lead us to propose in post-operative situation, in patients with a squamous cell carcinoma of the head and neck, a radiochemotherapy with Cisplatin followed by a treatment of maintenance by Afatinib or by placebo.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Paul Papin, Angers, , France

Institut Sainte-Catherine, Avignon, , France

CHU Bordeaux - Hôpital Saint-André, Bordeaux, , France

Polyclinique de Bordeaux Nord, Bordeaux, , France

CHRU Brest - Hôpital Morvan, Brest, , France

Centre François Baclesse, Caen, , France

CHIC Créteil, Créteil, , France

Centre Guillaume le Conquérant, Le Havre, , France

Centre Hospitalier Bretagne Sud, Lorient, , France

Centre Léon Bérard, Lyon, , France

AP-HM La Timone Adultes, Marseille, , France

Centre Antoine Lacassagne, Nice, , France

CHU Poitiers, Poitiers, , France

Centre Eugène Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Institut de Cancérologie de la Loire, Saint Priest en Jarez, , France

Institut de Cancérologie de l'Ouest, Saint-Herblain, , France

Pôle Hospitalier Mutualiste- Centre Etienne Dolet, Saint-Nazaire, , France

Strasbourg Oncologie Libérale, Strasbourg, , France

Hopitaux du Léman, Thonon-les-bains, , France

Clinique Pasteur Bâtiment l'Atrium, Toulouse, , France

Institut Claudius Regaud, Toulouse, , France

CHU TOURS (Hôpital Bretonneau), Tours, , France

Centre de Radiothérapie Marie Curie, Valence, , France

Institut de Cancérologie de lorraine (ICL), Vandoeuvre-les-Nancy, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Séverine RACADOT, MD

Affiliation: Centre Léon Bérard; Lyon

Role: PRINCIPAL_INVESTIGATOR

Name: Pascal POMMIER, MD

Affiliation: Centre Léon Bérard , Lyon

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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