The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Séverine RACADOT, MD
Affiliation: Centre Léon Bérard; Lyon
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal POMMIER, MD
Affiliation: Centre Léon Bérard , Lyon
Role: PRINCIPAL_INVESTIGATOR