Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy) - Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)

Takehara Tetsuo0 个研究点目标入组 30 人开始时间: 2019年3月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Clinical stage IA (cT1a or cT1bN0M0) esophageal cancer (Histologically proven squamous cell carcinoma of the esophagus)
•2) Aged >= 20 years old
•3) ECOG PS of 0 or 1
•4) Adequate food intake
•5) No esophageal cancer including HGIN out of radiation field
•6) Adequate organ functions
•a) WBC: >=3,000/mm3, <12,000/mm3
•b) Neu: >=1,500/mm3c) Hb: >=9.0g/dl
•d) Plt: >=100,000/mm3
•e) T.bil: <2.0mg/dl
•f) AST/ALT: <150IU/L
•g) Cr: <1.2mg/dl
•h) CCr: >=50ml/min (in favor of the prediction formula of Cockcroft-Gault: Male; CCr = body weight x (140-age) / (72 x Cr), Female; CCr= body weight x (140-age) / (72 x Cr) x 0.85)
•7) Written informed consent

•1) Previous treatment with pyrimidine fluoride drug or platinum within 5 years
•2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure)
•3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
•4) History of severe allergic reactions to pyrimidine fluoride drug or platinum
•5) Active infection
•6) Positive HBs antigen
•7) Previous radiotherapy to chest
•8) With severe diarrhea
•9) Psychosis
•10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
•11) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
•12) Any patients judged by the investigator to be unfit to participate in the study

发起方

Takehara Tetsuo