The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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, Spain
• Complete clinical response rate and objective clinical response rate after the administration of 3 cycles of chemotherapy plus cetuximab and after induction chemotherapy followed by concomitant chemoradiotherapy plus cetuximab
Time frame: 2006-2010
• To determine the complete pathological response rate in the patients subject to radical surgery, according to the investigators' criteria and the policy of each centre.
Time frame: 2006-2010
Adverse events
Time frame: 2006-2010
• To study the locoregional control of the disease, the therapeutic failure patterns, specific disease-free survival, event-free survival, disease-specific survival and global survival
Time frame: 2006-2012
• To determine EGFR expression in the tumour and attempt to correlate it with efficacy
Time frame: 2006-2010
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