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

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ClinicalTrials.gov Identifier: NCT01467921
Recruitment Status : Unknown
Verified November 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2010
Estimated Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01467921     History of Changes
Other Study ID Numbers: 2010-07-206
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs