drugset / Trial / NCT01867892
A Phase II Study of Locally Advanced Pancreatic Cancer
Phase 2
Unknown
86 enrolled
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.
Timeline
- Start
- 2013-06
- Primary completion
- 2018-05
- Completion
- 2019-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 450 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 3000 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 150 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |