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Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Conditions
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: oxaliplatin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
- 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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Mi yeon kwon, RN - +82-2-3410-1248 - miyeon.kwon@samsung.com
Start Date
December 2010
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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