esophageal cancer (clinical stage IA)
Conditions
Interventions
Concurrent chemoradiotherapy with 5-FU and cisplatin followed by S-1
Sponsors
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 7) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Complete Response Rate, Preservation rate, Relative dose intensity, Adverse event | — |
Countries
Japan
Contacts
Public ContactYoshito Hayashi
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed