Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: TS-1 and cisplatin
* Drug: TS-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TS-1 and cisplatin | Drug: TS-1 and cisplatin<br>* 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.<br>|
| Active Comparator: 2<br>TS-1 | Drug: TS-1<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach cancer