clinical stage IA esophageal cancer
Conditions
Interventions
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus 2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae) 3) Aged 20 to 80 years old 4) ECOG PS of 0, 1 or 2 5) Clinical stage IA (cT1a or cT1bN0M0) or pT1 which need therapy 6) No need for measurable lesion 7) No previous treatment of esophageal cancer 8) Adequate food intake 9) No palsy of recurrent nerve 10) Adequate organ functions 11) Refused esophagectomy 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Uncontrollable diabetes millutus 4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure 5) Uncontrollable arrhythmia 6) Patients requiring systemic steroids medication 7) Liver cirrhosis 8) Active bacterial or fungous infection 9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0 10) With grade 2-4 nerve disturbance by CTCAE version 4.0 11) With blood transfusion within 2 weeks and/or active bleeding 12) Interstitial pneumonia, fibroid lung or severe emphysema 13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo) 14) Psychosis 15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Adverse event | — |
Countries
Japan
Contacts
Public ContactSachiko Yamamoto
Osaka International Cancer Institute Department of Gastrointestinal Oncology
Outcome results
None listed