Status:
COMPLETED
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plu...
Eligibility Criteria
Inclusion
- Non-prior chemotherapy treated advanced gastric adenocarcinoma
- Age 18 and over
- Performance status 0, 1, or 2 (ECOG)
- Life expectancy 3 months
- Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
- Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
- Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min
Exclusion
- Interstitial pneumonia, pulmonary fibrosis
- Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
- Intestinal paralysis, intestinal obstruction, uncontrollable diabetes
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00202969
Start Date
July 1 2005
End Date
June 1 2007
Last Update
July 7 2011
Active Locations (1)
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1
Beijing Cancer Hospital
No.52 Fu-Cheng Road, Hai-dian District, Beijing Municipality, China