Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.

Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 120 人开始时间: 2010年12月1日最近更新: 2023年10月17日

研究概览

暂无简介。

•1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma.
•2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
•3) No prior radiotherapy, chemotherapy or hormone therapy.
•4) Adequate organ functions:
•i) WBC >=3000/mm3 and <=12000/mm3,
•ii) neutrophils >=2000/mm3,
•iii) platelets >=100,000/mm3,
•iv) hemoglobin >=8.0g/dL,
•v) total bilirubin <=1.5mg/dL,
•vi) AST(GOT)/ALT(GPT) <=100IU/L,
•vii) creatinine clearance >=50mL/min.
•5) ECOG Performance status:0-2
•6) Expected survival over 3 months.
•7) Age of 20 years or older.
•8) Sufficient oral intake.
•9) Normal ECG.
•10) Written informed consent.

•1) Limitation of use of TS-1.
•2) Infection and inflammation.
•3) Serious heart disease.
•4) Symptomatic pulmonary fibrosis or interstitial pneumonia.
•5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis.
•6) A large amount of pleural effusion or peritoneal fluid.
•7) Widespread bone-marrow metastases.
•8) Brain metastasis.
•9) Fresh bleeding from digestive organs.
•10) Diarrhea.
•11) Severe mental disorders.
•12) Active synchronous malignancy.
•13) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
•14) Pregnant females, possibly pregnant
•females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
•15) Other patients who are unfit for the study as determined by the attending physician.

发起方

Japanese Foundation for Multidisciplinary Treatment of Cancer