esophageal cancer
Conditions
Interventions
Chemotherapy using Docetaxel+Cisplatin+S-1
Sponsors
Second Department of Surgery, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan. (2)ECOG perfprmance status 0-1. (3)Tissue from tumor must be available. Patients must have measurable disease. (4)Patients may have received prior chemotherapy or radiotherapy; this must have beed completed at least 4 weeks. Patients may have received prior surgery or ESD; this must have beed completed at least 3 weeks. Patients may have received prior immunotherapy; this must have beed completed at least 1 week. (5)Life expectancy > 3 months. (6)Laboratory values as follows. 2000/mm3 < WBC < 12000/mm3 granulocyte count > 1500/mm3 hemoglobin > 8.0 g/dl Platelet count > 100000/mm3 AST ALT < 150 IU/L T-bil < 1.5 mg/dl Creatinine < 1.5
Exclusion criteria
Exclusion criteria: (1)Pregnency. (2)Active or uncontrolled infection. (3)Patients with a history of myocardial infarction within the previous 3 months. (4)Patients with uncontrolled diabetes melitus or hypertension. (5)Patients with clinically apparent central nervous system metastases (6)Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Safety (Toxicities as assessed by NCI CTCAE ver. 4) Phase II: Clinical response of chemotherapy(Feasibility as evaluated by RECIST ver 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Toxicities as assessed by NCI CTCAE ver. 4 Time to progression Median survival time | — |
Countries
Japan
Contacts
Public ContactToshiyasu Ojima
Wakayama Medical University Second Department of Surgery
Outcome results
None listed