Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients
with histological stage IV Pancreatic cancer given gemcitabine plus S-1. The usefulness of
this regimens as 1st line therapy for pancreatic cancer was evaluated by the disease-free
survival(DFS), median survival time (MST), incidence and severity of adverse event.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
Masahiro Asaka, MD, PhD
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare