Neo-adjuvant combination chemotherapy of Tranilast in esophageal carcinoma (TNAC)

Recruiting

• Conditions: advanced esophageal squamous cell carcinoma

• Registration Number: jRCTs051190076

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-29
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 59

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.
8. Oral and written informed consent obtained before registration

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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Pathological therapeutic effect