Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 TS-1 and cisplatin |
Drug: TS-1 and cisplatin
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.
|
| Active Comparator: 2 TS-1 |
Drug: TS-1
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 Measures
Primary Outcome Measures
- Overall survival [every course for first three courses, then every other course]
Secondary Outcome Measures
- Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile [every course for first three courses, then every other course]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed adenocarcinoma
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Unresectable and recurrent gastric cancer
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Age 20 to 74
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Performance status 0, 1, or 2 (ECOG)
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Life expectancy 3 months
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No prior chemotherapy or radiotherapy for gastric cancer
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Able to take oral medication
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Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
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Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm3 Platelet ≥ 100,000/mm3 Hemoglobin ≥ 8.0 g/dL
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Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
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Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min
Exclusion Criteria:
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Pregnant or nursing
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Bleeding from gastrointestinal tract or no diarrhea
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Hypersensitivity to TS-1 or CDDP
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Psychiatric disorder that would preclude study compliance or giving informed consent
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Severe acute or chronic medical or psychiatric condition or laboratory abnormality
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Serious illness or medical condition
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Brain metastasis
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Ascites requiring drainage
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | East Hospital, Kitasato University | 2-1-1, Asamizodai, Sagamihara | Kanagawa | Japan |
Sponsors and Collaborators
- Taiho Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Wasaburo Koizumi, MD, PHD, East Hospital, Kitasato University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 91023039