Back to resultsILF With/Without Cisplatin for Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasm
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
irinotecan
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm
Eligibility Criteria
Inclusion Criteria: Histologically proven gastric adenocarcinoma Advanced, metastatic or recurrent ECOG performance status 0 to 2 No prior chemotherapy Measurable or evaluable indicator lesion(s) Normal marrow, hepatic and renal functions Provision of written informed consent Exclusion Criteria: Active infection, bleeding or severe comorbidities Pregnant or breastfed women Active CNS metastasis
Sites / Locations
- Gachon University Gil Medical Center
Outcomes
Primary Outcome Measures
Objective response rate
Safety
Secondary Outcome Measures
Progression-free survival
Overall survival
Quality of life
Full Information
NCT ID
NCT00320294
First Posted
May 1, 2006
Last Updated
March 9, 2007
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00320294
Brief Title
ILF With/Without Cisplatin for Advanced Gastric Cancer
Official Title
A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
Brief Summary
To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.
Detailed Description
Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen [Pozzo C, et al. Ann Oncol 2004]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Type
Drug
Intervention Name(s)
cisplatin
Primary Outcome Measure Information:
Title
Objective response rate
Title
Safety
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall survival
Title
Quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven gastric adenocarcinoma
Advanced, metastatic or recurrent
ECOG performance status 0 to 2
No prior chemotherapy
Measurable or evaluable indicator lesion(s)
Normal marrow, hepatic and renal functions
Provision of written informed consent
Exclusion Criteria:
Active infection, bleeding or severe comorbidities
Pregnant or breastfed women
Active CNS metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Hoon Park, MD
Organizational Affiliation
Gachon University Gil Medical Center, Incheon, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405 760
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18083691
Citation
Park SH, Nam E, Park J, Cho EK, Shin DB, Lee JH, Lee WK, Chung M, Lee SI. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol. 2008 Apr;19(4):729-33. doi: 10.1093/annonc/mdm502. Epub 2007 Dec 13.
Results Reference
derived
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ILF With/Without Cisplatin for Advanced Gastric Cancer
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