Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
NCT ID: NCT01467921
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LV5FU2
leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2
oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
FOLFOX
leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Interventions
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oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior treatment with oxaliplatin
* Pregnant or lactating women
* Active CNS metastases not controllable with radiotherapy or corticosteroids
* Known history of hypersensitivity to study drugs
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010-07-206
Identifier Type: -
Identifier Source: org_study_id