NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Advanced 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 : S-1 (tegafur + gimeracil + oteracil potassium), CDDP INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium, CDDP:cisplatin Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 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. control material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks. Generic name etc : 5-FU, CDDP INN of investigational material : 5-FU:fluorouracil, CDDP:cisplatin Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 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.

Outcome(s)

Primary Outcome	Antitumor effect and time to treatment failure
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Non-prior chemotherapy treated advanced gastric cancer. 2)Non-resectable, locally-advanced or metastatic gastric cancer which is histologically confirmed adenocarcinoma.
Exclude criteria