Status:
COMPLETED
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
Detailed Description
This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastri...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma
- Unresectable and recurrent gastric cancer
- Age 20 to 74
- Performance status 0, 1, or 2 (ECOG)
- Life expectancy 3 months
- No prior chemotherapy or radiotherapy for gastric cancer
- Able to take oral medication
- Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
- Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm\^3 Platelet ≥ 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 ≥ 50 mL/min
Exclusion
- Pregnant or nursing
- Bleeding from gastrointestinal tract or no diarrhea
- Hypersensitivity to TS-1 or CDDP
- Psychiatric disorder that would preclude study compliance or giving informed consent
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
- Serious illness or medical condition
- Brain metastasis
- Ascites requiring drainage
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00150670
Start Date
March 1 2002
End Date
December 1 2006
Last Update
July 7 2011
Active Locations (1)
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1
East Hospital, Kitasato University
2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan