Stomach Neoplasm
Conditions
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.
Interventions
DRUGirinotecan
DRUGcisplatin
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
| Quality of life | — |
Countries
South Korea
Outcome results
None listed