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

This study is currently recruiting participants.
Verified November 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01467921
First received: November 6, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
 Drug: oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: December 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
 Drug: oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Experimental: 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
 Drug: oxaliplatin
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467921

Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Mi yeon kwon, RN     +82-2-3410-1248     miyeon.kwon@samsung.com    
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01467921     History of Changes
Other Study ID Numbers: 2010-07-206
Study First Received: November 6, 2011
Last Updated: November 14, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013