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.
Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Both
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Outcome Time Frame:
36 months
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
2010-07-206
NCT ID:
NCT01467921
Start Date:
December 2010
Completion Date:
Related Keywords:
- Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Diseases
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