advanced esophageal squamous cell carcinoma Esophageal Squamous Cell Carcinoma
Conditions
Interventions
The additional use of tranilast to conventional neoadjuvant chemotherapy (5-FU/CDDP) for advanced esophageal squamous cell carcinoma patients
Sponsors
Shiozaki Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven esophageal squamous cell carcinoma 2) Clinically diagnosed Stage II or Stage III esophageal squamous cell carcinoma patients in Japanese Classification of Esophageal Cancer, 11th edition 3) A case who was judged to be able to undergo radical esopagctomy under the general anesthesia 4) Age between 20 and 74 years old 5) A cases with ECOG Performance status 0,1 or 2 6) an essentially normal clinical laboratory profile (serum creatinine: =60 ml/minute; total serum bilirubin: =4,000 /mm3; haemoglobin: >=10g /dl; platelet count: >=100,000 /mm3 7) A case that can take medicine. 8) Oral and written informed consent obtained before registration
Exclusion criteria
Exclusion criteria: 1) A history of chemotherapy or radiotherapy 1 year before treatment begins 2) Tumor with active bleeding 3) A case with histories of acute myocardial infarction, severe angina, congested heart failure, cerebrovascular disease, or pulmonary thrombosis within 6 months before registration 4) A case with uncontrolled asthma 5) A history of laparotomy or trachotomy within 4 weeks before treatment begins 6) A case with allergy of tranilast 7) A female with a possibility of pregnancy, breastfeeding to infant, and desire to bear children 8) A case judged as inappropriate for the present clinical trial by the chief researcher 9) A case that take some similar drugs to tranilast 10) A case with transfusion within 14 days before registration 11) Current medication of warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological therapeutic effect | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical safety, therapeutic response diagnosed by imaging examination, down staging, ontological outcomes, | — |
Contacts
Public ContactMichihiro Kudou
University Hospital Kyoto prefectural University of Medicine
Outcome results
None listed