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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

• NCT number: NCT03316326
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Shih-Hung Yang, M.D.
• Phone: +886-2-23123456
• Email: 018500@ntuh.gov.tw
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2017
• Completion date: December 31, 2021