Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly
patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness
of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free
survival rate (DFR), overall survival rate (OS), 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. Determine the clinical response rate with Recommended dose in Phase II setting.
Masahiro Asaka, MD, PhD
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare