Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer|
- 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. [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
- Determine the clinical response rate of patients in Phase I setting. [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
- Determine the OS(Overall Survival) and DFS(Disease Free Survival). [ Time Frame: 2-years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Docetaxel plus S-1
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
Other Name: DocetaxelDrug: TS-1
Day 1-14, P.O. everyday
Other Name: S-1
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209729
|Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)|
|Sapporo, Hokkaido, Japan, 060-8638|
|Study Chair:||Masahiro Asaka, MD, PhD||Hokkaido Gastrointestinal Cancer Study Group|