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Japanese

Nov. 29, 2019

Feb. 22, 2024

jRCTs051190076

Clinical safety and efficacy of neo-adjuvant combination chemotherapy of Tranilast in advanced esophageal squamous cell carcinoma: phase I/II study (TNAC)

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

Shiozaki Atsushi

University Hospital Kyoto prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN.

+81-752515527

shiozaki@koto.kpu-m.ac.jp

Kudou Michihiro

University Hospital Kyoto prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN.

+81-752515527

posit@koto.kpu-m.ac.jp

Recruiting

Nov. 14, 2019

59

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

20age old over
74age old under

Both

advanced esophageal squamous cell carcinoma

The additional use of tranilast to conventional neoadjuvant chemotherapy (5-FU/CDDP) for advanced esophageal squamous cell carcinoma patients

Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma

Pathological therapeutic effect

clinical safety, therapeutic response diagnosed by imaging examination, down staging, ontological outcomes,

Kyoto Prefectural University of Medicine, Clinical Research Review Board
465 Kajii-cho, Kamigyo-ku Kyoto 6028566 JAPAN, Kyoto

+81-75-251-5337

rinri@koto.kpu-m.ac.jp
Approval

Aug. 30, 2019

Yes

none

History of Changes

No Publication date
4 Feb. 22, 2024 (this page) Changes
3 Aug. 02, 2023 Detail Changes
2 Mar. 02, 2021 Detail Changes
1 Nov. 29, 2019 Detail