Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
- To determine the maximum tolerated dose of fluorouracil and cisplatin when administered
with cetuximab concurrently with esophageal radiotherapy. (Phase I)
- To determine the complete histological response rate (after surgical resection). (Phase
- To determine progression-free survival and overall survival. (Phase II)
- To determine the rate of resection with negative margins (R0). (Phase II)
- To determine the overall tolerance to neoadjuvant therapy. (Phase II)
- To determine the postoperative morbidity and mortality. (Phase II)
OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and
Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15,
22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV
continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5
days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.
After completion of study therapy, patients are followed at 1 month, every 4 months for 2
years, and then every 6 months for 2 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete histologic response
Federation Francophone de Cancerologie Digestive