NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Advanced (nonresectable/recurrent) gastric cancer
Date of first enrollment	07/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium), CDDP (cisplatin) INN of investigational material : TS-1:tegafur, gimeracil, oteracil potassium , CDDP:cisplatin Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle. control material(s) Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : TS-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.

Outcome(s)

Primary Outcome	Survival and adverse events
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with nonresectable or recurrent gastric cancer which is histologically confirmed adenocarcinoma.
Exclude criteria