A Study to Evaluate the Combination of Cetuximab and Chemotherapy as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy Plus Cetuximab in Locoregional Esophageal Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Esophageal Carcinoma
Interventions
DRUG

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"

Trial Locations (1)

28046

Spanish Cooperative Group for Gastrointestinal Tumour Therapy, Madrid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER