JPRN-jRCTs051190076
Recruiting
Phase 1
Clinical safety and efficacy of neo-adjuvant combination chemotherapy of Tranilast in advanced esophageal squamous cell carcinoma: phase I/II study - TNAC
Shiozaki Atsushi0 sites59 target enrollmentNovember 29, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shiozaki Atsushi
- Enrollment
- 59
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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: \<\=1\.2 mg /dl; (creatinine clearance or CCr) \>\=60 ml/minute;
- •total serum bilirubin: \<\=1\.2 mg /dl; aspartate aminotransaminase or AST and
- •alanine aminotransaminase or ALT: no higher than twice upper limit of normal value defined in our institution; white blood cell count: \>\=4,000 /mm3; haemoglobin: \>\=10g /dl; platelet count: \>\=100,000 /mm3
- •7\) A case that can take medicine.
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
Outcomes
Primary Outcomes
Not specified
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