Spots Global Cancer Trial Database for S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
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Trial Identification
Brief Title: S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
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
Study ID: NCT03316326
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Yu-Wen Tien, M.D., Ph. D.
Affiliation: National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR
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