Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach cancer
Eligibility Criteria
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
Sites / Locations
- East Hospital, Kitasato University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
TS-1 and cisplatin
TS-1