esophageal cancer
Conditions
Sponsors
Kyoto university hospital
Medical research support company with limited liability
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage IB-III(without T4 disease) 4) Aged 20 to 75 years old 5) ECOG PS of 0 or1 6) Performed neoadjuvant chemotherapy (5-FU+cisplatin) 7) No previous treatment of esophageal cancer except EMR or ESD 8) Adequate organ functions 9) Resectable disease (R0) 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Positive HBs antigen, or positive HCV antibody. 4) Pregnancy, possible pregnancy or breastfeeding. 5) Psychiatric disease. 6) Patients who need flucitosine, fenitoin or warfarin. 7) Poorly controlled diabetes mellitus 8) Severe pulmonary fibrosis or emphysema. 9) Serious angina or myocaedial infarcion within 3 months 10) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year relapse free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, time to treatment free survival, treatment completion rate, incidence of adverse events, incidence of treatment related death | — |
Countries
Japan
Contacts
Public ContactMotoo Nomura
Kyoto university hospital Department of Clinical Oncology
Outcome results
None listed