ILF With/Without Cisplatin for Advanced Gastric Cancer
- Conditions
- Stomach Neoplasm
- Registration Number
- NCT00320294
- Lead Sponsor
- Gachon University Gil Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 86
- 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
- Active infection, bleeding or severe comorbidities
- Pregnant or breastfed women
- Active CNS metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective response rate Safety
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival Quality of life
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of