esophageal cancer (stage0/IA)
Conditions
Interventions
Endoscopic submucosal dissection after DCF combination chemotherapy
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinical stage 0/IA esophageal cancer according to UICC-TNM classification ver. 7 2) Extra indication of endoscopic treatment by circumference, size or depth 3) Aged >= 20 years old 4) ECOG PS 0 or 1 5) Possibility of oral intake 6) No previous history of treatment for esophageal cancer except non-invasive cancer 7) Adequate organ functions 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previous treatment with pyrimidine fluoride, taxane, or platinum within 5 years 2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncotrollable diabetes mellitus or hypertention, history of myocardial infarction within 6 months, or unstable angina, liver cirrhosis, renal failure) 3) Simultaneous or metachronous cancers with the exception of cured malignancies with prior therapy 4) History of severe allergic reactions to pyrimidine fluoride drug, taxane, or platinum 5) Impossible discontuniation of anti thrombotic therapy 6) Active infection 7) Positive HBs antigen 8) Previous radiotherapy to chest 9) Continuous steroid administration 10) History of allergic reaction to iodine 11) Severe diarrhea 12) Psychosis 13) Pregnant or lactating women, women of childbearing potential or women who like to have children in future 14) Patiets requiring the administration of flucytosine, phenytoin or warfarin potassium 15) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic resectability by ESD | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological curability, overall survival, progression free survival, safety of DCF chemotherapy, adverse events of ESD, the preservation rate of esophagus | — |
Countries
Japan
Contacts
Public ContactYoshito Hayashi
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed