Gastric Cancer
Conditions
Keywords
Stomach cancer
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 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.
Interventions
DRUGTS-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.
DRUGTS-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.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | every course for first three courses, then every other course |
Secondary
| Measure | 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 |
Countries
Japan
Outcome results
None listed