Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer (definitive chemoradiotherapy)
- Conditions
- esophageal cancer (clinical stage IA)
- Registration Number
- JPRN-UMIN000015938
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Complete Response Rate, Preservation rate, Relative dose intensity, Adverse event