- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320294
ILF With/Without Cisplatin for Advanced Gastric Cancer
March 9, 2007 updated by: Gachon University Gil Medical Center
A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
86
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Incheon, Korea, Republic of, 405 760
- Gachon University Gil Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
Objective response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Overall survival
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Quality of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Study Completion
March 1, 2007
Study Registration Dates
First Submitted
May 1, 2006
First Submitted That Met QC Criteria
May 2, 2006
First Posted (Estimate)
May 3, 2006
Study Record Updates
Last Update Posted (Estimate)
March 12, 2007
Last Update Submitted That Met QC Criteria
March 9, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Irinotecan
Other Study ID Numbers
- GMO-GI-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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