S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Simon's two-stage optimum designMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 79 years
- Gender
- Both males and females
Description
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after n...
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.
Tracking Information
- NCT #
- NCT03316326
- Collaborators
- TTY Biopharm
- Investigators
- Principal Investigator: Yu-Wen Tien, M.D., Ph. D. National Taiwan University Hospital
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