144
Participants
Start Date
October 31, 2013
Primary Completion Date
July 31, 2020
Study Completion Date
April 28, 2022
Cisplatin
A total of three cycles of cisplatin will be administered in a 1-hour IV infusion on days 2, 23 and 44. Cisplatin will be administered 0.5 hours after Debio 1143.
Radiotherapy
Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.
Debio 1143
Debio 1143 solution
Placebo
Matching placebo solution
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4, Bern
Hôpital Nord Franche-Comté, Montbéliard
Institut Claudius Regaud, Toulouse
ICM - Val D'Aurelle, Montpellier
Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF, Lorient
Institut Curie, Paris
Centre Henri Becquerel, Rouen
Centre Guillaume le Conquérant, Le Havre
C.H.U. Sud Amiens, Amiens
Institut Sainte-Catherine, Avignon
Institut Gustave Roussy, Villejuif
Centre Jean Perrin, Clermont-Ferrand
CHU Grenoble, Grenoble
Institut de Cancérologie de l'Ouest (ICO) René Gauducheau, Saint-Herblain
CHD Vendée, La Roche-sur-Yon
Centre Jean Bernard, Le Mans
Institut de Cancérologie Lucien Neuwirth (ICLN), Saint-Priest-en-Jarez
L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin, Vandœuvre-lès-Nancy
Lead Sponsor
Debiopharm International SA
INDUSTRY