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ILF With/Without Cisplatin for Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Gachon University Gil Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by:
Gachon University Gil Medical Center Identifier:
First received: May 1, 2006
Last updated: March 9, 2007
Last verified: March 2007
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.

Condition Intervention Phase
Stomach Neoplasm
Drug: irinotecan
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Objective response rate
  • Safety

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival
  • Quality of life

Estimated Enrollment: 86
Study Start Date: February 2005
Estimated Study Completion Date: March 2007
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00320294

Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00320294     History of Changes
Other Study ID Numbers: GMO-GI-52
Study First Received: May 1, 2006
Last Updated: March 9, 2007

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017