drugset / Trial / NCT02172976
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX. The overall survival between both therapies will be compared as well as other parameters.
Timeline
- Start
- 2014-11
- Primary completion
- 2020-01
- Completion
- 2020-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Natriumfolinate | Unknown | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |