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NCT02938481 Clinical Trial

International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Colon Cancer Clinical Trial

— T-REX  

Official title:
International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02938481
Other study ID # TRICC1410
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 30, 2013
Est. completion date December 2023

Study information
Verified date July 2023
Source Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

Description:

In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area. To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4000
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Histologically proven colon adenocarcinoma - Pathological stage ?, ? or ? - Potentially curative surgery - Informed consent for observational data collection Exclusion Criteria: - Tis (mucosal cancer) - Multiple colon cancers - All patients with preoperative adjuvant therapy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Erlangen Erlangen Bayern
Japan Tokyo Medical and Dental University Bunkyo-ku Tokyo
Japan Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital Bunkyo-ku Tokyo
Japan National Canser Centre Hospital East Chiba-city Chiba-prefecture
Japan National Cancer Centre Central Hospital Chuo-ku Tokyo
Japan Teikyo University Chiba Medical Center Ichihara-shi Chiba-prefecture
Japan Teikyo University School of Medicine Itabashi-ku Tokyo
Japan Saitama Cancer Center Kitaadachi-gun Saitama-prefecture
Japan Takano Hospital Kumamoto-city Kumamoto-prefecture
Japan Kurume University School of Medicine Kurume-city Hukuoka-prefecture
Japan Kyorin University School of Medicine Mitaka-city Tokyo
Japan Aichi Cancer Centre Hospital Nagoya-city Aichi-prefecture
Japan Niigata Cancer Center Hospital Niigata-city Niigata-prefecture
Japan Osaka International Cancer Institute Osaka-city Osaka-prefecture
Japan Shiga University of Medical Science Otsu-shi Shiga-prefecture
Japan Keiyukai Sapporo Hospital Sapporo-city Hokkaido
Japan Tokyo Women's Medical University Shinjuku-ku Tokyo
Japan Shizuoka Cancer Centre Hospital Sunto-gun Shizuoka-prefecture
Japan National Defense Medical College Tokorozawa-city Saitama-prefecture
Japan Fujita Health University Toyoake Aichi
Japan Mie University Graduate School of Medicine Tsu-city Mie-prefecture
Japan Tochigi Cancer Center Utsunomiya-city Tochigi-prefecture
Japan Wakayama Medical University Wakayama-city Wakayama-prefecture
Japan Yamagata Prefectural Central Hospital Yamagata-city Yamagata-prefecture
Japan Yokohama City University Medical Center Yokohama Kanagawa
Japan Kanagawa Cancer Centre Hospital Yokohama-city Kanagawa-prefecture
Japan Saisei-kai Yokohama-shi Nanbu Hospital Yokohama-city Kanagawa-prefecture
Japan Yokohama-city University Yokohama-city Kanagawa-prefecture
Korea, Republic of Yonsei University Seodaemun-gu Seoul
Korea, Republic of University of Ulsan College of Medicine and Asan Medical Center Songpa-Gu Seoul
Lithuania Klaipeda University hospital Klaipeda Lietuva
Lithuania National Cancer Institute, Lithuania Vilnius
Russian Federation I.M. Sechenov First Moscow State Medical University Moscow
Taiwan China Medical University Hospital Taichung City
Taiwan National Taiwan University Hospital Taipei City
United Kingdom University of Leeds Leeds West Yorkshire

Sponsors (2)
Lead Sponsor Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan Tokyo Medical and Dental University, Japan

Countries where clinical trial is conducted

Germany,  Japan,  Korea, Republic of,  Lithuania,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of metastatic LNs At the time of patient registry in
Primary Distribution of metastatic LNs At the time of 4 years after surgery
Secondary Prognostic outcomes according to the length of bowel resection 4 years
Secondary Prognostic outcomes according to the central radicality 4 years
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