Esophageal Cancer
Conditions
Interventions
Paclitaxel 30-60mg/m2 (day1, 8, 15, 22, 29, 36) or 40-60mg/m2 (day1, 15, 29) Radiation 60Gy/30fr
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. 2) Primary tumor located in thoracic esophagus. Second tumors in cervical or abdominal esophagus which is indicated for EMR/ESD are also eligible. 3) Clinical stages IB, II or III (excluding T4) based on the 7th UICC-TNM classification. 4) Patients who are amenable to 60Gy radiation therapy. 5) >=70 years old. 6) i) >=70 and <80 year-old-patient, PS (ECOG) of 0 or 1, and Creatinine>=1.5mg/dl. ii) >=70 and <80 year-old-patient, PS (ECOG) of 2. iii) >=80 year-old-patient, PS (ECOG) of 0 and 1. 7) Patients have measurable and/or non-measurable disease according to RECIST ver1.1. 8) No prior treatment against esophageal cancer except for endoscopic resection. 9) No prior chemotherapy and radiation therapy. 10) Sufficient organ functions. i) Neutrophil >= 1500/mm3 ii) WBC < 12000/mm3 iii) Platelet >= 100000/mm3 iv) T.Bil =< 1.5mg/dL v) AST =< 100IU/L vi) ALT =< 100IU/L 11) refused esophagectomy. 12) 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) Infectious disease with systemic therapy indicated. 3) Severe psychiatric disease. 4) Continuous systemic steroid therapy. 5) Poorly controlled diabetes mellitus. 6) Severe pulmonary fibrosis or emphysema. 7) Unstable angina pectoris, or history of myocardial infarction within three months. 8) Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Phase I> The frequency of DLT (Dose Limiting Toxicity) <Phase II> Two year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| <Phase I> Adverse event, Overall survival, Progression-free survival, Complete response rate, Pharmacokinetics, Geriatric Assessment <Phase II> Complete response rate, Progression-free survival, Adverse event, Late toxicity, Pharmacokinetics, Geriatric Assessment | — |
Countries
Japan
Contacts
Public ContactYasuo Hamamoto, Kenro Hirata
Keio University School of Medicine Gastroenterology and Hepatology
Outcome results
None listed