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

Primary Purpose

Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LV5FU2

FOLFOX

Arm Description

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

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

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

Full Information

First Posted
November 6, 2011
Last Updated
November 14, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01467921
Brief Title
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LV5FU2
Arm Type
Active Comparator
Arm Description
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
Arm Title
FOLFOX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mi yeon kwon, RN
Phone
+82-2-3410-1248
Email
miyeon.kwon@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi yeon kwon, RN
Phone
+82-2-3410-1248
Email
miyeon.kwon@samsung.com

12. IPD Sharing Statement

Learn more about this trial

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

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