NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
Summary
This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.
Timeline
- Start
- 2021-05-27
- Primary completion
- 2024-12-08
- Completion
- 2027-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Losartan | Other / unclassified | — | Oral |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |