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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Fluorouracil; Oxaliplatin

Criteria

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