Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

January 31, 2007

Study Completion Date

June 30, 2007

Conditions
Gastric Cancer
Interventions
DRUG

S-1

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.

DRUG

S-1 plus CDDP

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.

DRUG

5-FU plus CDDP

5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.

Trial Locations (1)

Unknown

Beijing Cancer Hospital, No.52 Fu-Cheng Road, Hai-dian District

All Listed Sponsors
lead

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

NCT00202969 - Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer | Biotech Hunter | Biotech Hunter