Neo-adjuvant combination chemotherapy of Tranilast in esophageal carcinoma

JRCT ID: jRCTs051190076

Registered date:29/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced esophageal squamous cell carcinoma
• Date of first enrollment: 14/11/2019
• Target sample size: 59
• Study type: Interventional
• Intervention(s): The additional use of tranilast to conventional neoadjuvant chemotherapy (5-FU/CDDP) for advanced esophageal squamous cell carcinoma patients

Outcome(s)

• Primary Outcome: Pathological therapeutic effect
• Secondary Outcome: clinical safety, therapeutic response diagnosed by imaging examination, down staging, ontological outcomes,

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shiozaki Atsushi