A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Se Hoon Park, MD
Gachon University Gil Medical Center, Incheon, Korea
Korea: Food and Drug Administration