ILF With/Without Cisplatin for Advanced Gastric Cancer
This trial is active, not recruiting.
|Sponsor||Gachon University Gil Medical Center|
|Start date||February 2005|
|End date||March 2007|
|Trial size||86 participants|
|Trial identifier||NCT00320294, GMO-GI-52|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Objective response rate
Quality of life
Male or female participants from 18 years up to 75 years old.
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
|Official title||A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer|
|Principal investigator||Se Hoon Park, MD|
|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.|
Call for more information