50
Participants
Start Date
December 31, 2006
Primary Completion Date
November 30, 2012
Study Completion Date
November 30, 2012
cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)
"Neoadjuvant chemotherapy plus cetuximab:~3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy.~Radio-chemotherapy plus cetuximab:~The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks).~Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36"
Spanish Cooperative Group for Gastrointestinal Tumour Therapy, Madrid
Collaborators (1)
Merck Sharp & Dohme LLC
INDUSTRY
Sanofi
INDUSTRY
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER