60
Participants
Start Date
July 31, 2008
Primary Completion Date
March 31, 2012
Study Completion Date
December 31, 2015
IV cetuximab
Cetuximab is administered every two weeks at the dose of 500 mg/m² over 2h30 (150 minutes).
HAI chronomodulated chemotherapy
"Irinotecan (180 mg/m²) on day 2 as a 6 hour infusion, starting at 2:00, with a peak at 5:00~Oxaliplatin (85 mg/m²) in split daily doses for 3 days, starting on day 2. Daily sinusoidal infusion duration will last from 10:15 to 21:45, with peak delivery rate at 16:00.~5-Fluorouracil (2800 mg/m²) in split daily doses for 3 days, alternating with oxaliplatin infusions, starting on day 2. Daily sinusoidal infusions will last from 22:15 to 9:45 , with peak delivery at 4:00.~Treatments will be repeated every 2 weeks."
HAI conventional chemotherapy
"Irinotecan (180 mg/m²) on day 1 as a one hour infusion, then~Oxaliplatin (85 mg/m²) on day 1 as a two hour infusion, then~5-Fluorouracil (2800 mg/m²) as a 48 h infusion starting on day 2, after completion of oxaliplatin delivery.~Treatments will be repeated every 2 weeks."
Clinique Saint-Joseph, Liège
Hospital Fernando Fonesca, Amadora
CHU Toulouse, Toulouse
CHU de Bordeaux, Hôpital Saint-André, Bordeaux
Azienda Ospedaliera S.Maria Degli Angeli, Pordenone
CHRU de Lille, Hôpital Claude Huriez, Lille
Centre Jean Perrin, Clermont-Ferrand
Università G. d'Annunzio, Chieti
Hôpital Cochin, Paris
Hôpital Européen Georges Pompidou, Paris
Hôpital Ambroise Paré, Boulogne-Billancourt
Chronotherapy Unit, Medical Oncology Department, Paul Brousse Hospital, Villejuif
Institut Gustave Roussy, Villejuif
Istituto Regina Elena, Roma