Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.

Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.

Inclusion Criteria:

• Aged 20 years or older
• Histologically confirmed squamous cell carcinoma of esophagus
• Curatively (R0) resected, lymph node positive
• ECOG performance status of 0 or 1
• Restoration of oral intake >1500 kcal/d
• No prior chemotherapy except for neoadjuvant ones
• No prior radiotherapy within 1 month before registration
• Adequate marrow, hepatic, renal and cardiac functions
• Provision of a signed written informed consent

Exclusion Criteria:

• Severe co-morbid illness and/or active infections
• Prior treatment with oxaliplatin
• Pregnant or lactating women
• Active CNS metastases not controllable with radiotherapy or corticosteroids
• Known history of hypersensitivity to study drugs