drugset / Trial / NCT02896803
Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil bolus and oxaliplatin). The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.
Timeline
- Start
- 2016-08
- Primary completion
- 2021-07
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |