drugset / Trial / NCT02355119
Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm. A total of 310 patients will be enrolled in about 50 Italian centers.
Timeline
- Start
- 2015-01
- Primary completion
- 2017-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |