Status:
UNKNOWN
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01467921
Start Date
December 1 2010
Last Update
November 16 2011
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea