NCT03316326

S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer

A Phase II Study of S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer (SIROX Study) - Followed by Curative Surgery and Adjuvant Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Tegafur-gimeracil-oteracil potassium	40 mg bid, D1-14
DRUG	Oxaliplatin	85 mg/m2, D1
DRUG	Irinotecan	150 mg/m2, D8

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-10-20
• Last updated: 2017-10-20