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ILF With/Without Cisplatin for Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00320294
Recruitment Status : Unknown
Verified March 2007 by Gachon University Gil Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2006
Last Update Posted : March 12, 2007
Sponsor:
Information provided by:
Gachon University Gil Medical Center

May 1, 2006
May 3, 2006
March 12, 2007
February 2005
Not Provided
  • Objective response rate
  • Safety
Same as current
Complete list of historical versions of study NCT00320294 on ClinicalTrials.gov Archive Site
  • Progression-free survival
  • Overall survival
  • Quality of life
Same as current
Not Provided
Not Provided
 
ILF With/Without Cisplatin for Advanced Gastric Cancer
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Neoplasm
  • Drug: irinotecan
  • Drug: cisplatin
Not Provided
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. Epub 2007 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
86
Same as current
March 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00320294
GMO-GI-52
Not Provided
Not Provided
Not Provided
Not Provided
Gachon University Gil Medical Center
Not Provided
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
Gachon University Gil Medical Center
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP