drugset / Trial / NCT02241551
Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.
Timeline
- Start
- 2014-12
- Primary completion
- 2017-03-03
- Completion
- 2017-03-03
Outcome
Outcome not reported
Stopped: “Study was terminated with the IRB ended early as logistical concerns of the SBRT”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |