Esophageal cancer Esophageal cancer
Conditions
Interventions
Sponsors
Yamamoto Sachiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid 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 (surgery, radiotherapy, chemotherapy),except for endoscopic surgery. 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 patients curable with therapy before diagnosis of esophageal cancer and patients with superficial cancer that is curable even before local treatment 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Uncontrollable diabetes mellitus 4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder 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 a history of grade 2-4 nerve disturbance by CTCAE version 4.0 11) With blood transfusion within 2weeks and/or active bleeding 12) Interstitial pneumonia, fibroid lung or severe emphysema 13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP), otastat potassium (Oxo) or platinum 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 |
|---|---|
| 1) without endoscopic surgery Complete response rate 2) with endoscopic surgery 3-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Adverse event | — |
Contacts
Public ContactSachiko Yamamoto
Osaka International Cancer Institute
Outcome results
None listed