International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer (T-REX)

July 19, 2023 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • University Hospital Erlangen
  • Japan
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Fujita Health University
    • Aichi-prefecture
      • Nagoya-city, Aichi-prefecture, Japan, 464-8681
        • Aichi Cancer Centre Hospital
    • Chiba-prefecture
      • Chiba-city, Chiba-prefecture, Japan, 277-8577
        • National Canser Centre Hospital East
      • Ichihara-shi, Chiba-prefecture, Japan
        • Teikyo University Chiba Medical Center
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 003-0027
        • Keiyukai Sapporo Hospital
    • Hukuoka-prefecture
      • Kurume-city, Hukuoka-prefecture, Japan, 830-0011
        • Kurume University School of Medicine
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Kanagawa-prefecture
      • Yokohama-city, Kanagawa-prefecture, Japan, 234-0054
        • Saisei-kai Yokohama-shi Nanbu Hospital
      • Yokohama-city, Kanagawa-prefecture, Japan, 236-0004
        • Yokohama-city University
      • Yokohama-city, Kanagawa-prefecture, Japan, 241-8515
        • Kanagawa Cancer Centre Hospital
    • Kumamoto-prefecture
      • Kumamoto-city, Kumamoto-prefecture, Japan, 862-0924
        • Takano Hospital
    • Mie-prefecture
      • Tsu-city, Mie-prefecture, Japan, 514-8507
        • Mie University Graduate School of Medicine
    • Niigata-prefecture
      • Niigata-city, Niigata-prefecture, Japan
        • Niigata Cancer Center Hospital
    • Osaka-prefecture
      • Osaka-city, Osaka-prefecture, Japan, 537-8511
        • Osaka International Cancer Institute
    • Saitama-prefecture
      • Kitaadachi-gun, Saitama-prefecture, Japan, 362-0806
        • Saitama Cancer Center
      • Tokorozawa-city, Saitama-prefecture, Japan, 359-8513
        • National Defense Medical College
    • Shiga-prefecture
      • Otsu-shi, Shiga-prefecture, Japan
        • Shiga University of Medical Science
    • Shizuoka-prefecture
      • Sunto-gun, Shizuoka-prefecture, Japan, 411-8777
        • Shizuoka Cancer Centre Hospital
    • Tochigi-prefecture
      • Utsunomiya-city, Tochigi-prefecture, Japan
        • Tochigi Cancer Center
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Centre Central Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8605
        • Teikyo University School of Medicine
      • Mitaka-city, Tokyo, Japan, 181-8611
        • Kyorin University School of Medicine
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University
    • Wakayama-prefecture
      • Wakayama-city, Wakayama-prefecture, Japan
        • Wakayama Medical University
    • Yamagata-prefecture
      • Yamagata-city, Yamagata-prefecture, Japan, 990-2292
        • Yamagata Prefectural Central Hospital
  • Korea, Republic of
    • Seoul
      • Seodaemun-gu, Seoul, Korea, Republic of, 03722
        • Yonsei University
      • Songpa-Gu, Seoul, Korea, Republic of
        • University of Ulsan College of Medicine and Asan Medical Center
  • Lithuania
      • Vilnius, Lithuania
        • National Cancer Institute, Lithuania
    • Lietuva
      • Klaipėda, Lietuva, Lithuania
        • Klaipeda University Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • I.M. Sechenov First Moscow State Medical University
  • Taiwan
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Taipei City, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with colon cancer who will receive potentially curative surgery at participating institutions between 22 Jan 2015 and 22 Jan 2020.

Description

Inclusion Criteria:

  • Histologically proven colon adenocarcinoma
  • Pathological stage Ⅰ, Ⅱ or Ⅲ
  • Potentially curative surgery
  • Informed consent for observational data collection

Exclusion Criteria:

  • Tis (mucosal cancer)
  • Multiple colon cancers
  • All patients with preoperative adjuvant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of metastatic LNs
Time Frame: At the time of patient registry in
At the time of patient registry in
Distribution of metastatic LNs
Time Frame: At the time of 4 years after surgery
At the time of 4 years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Prognostic outcomes according to the length of bowel resection
Time Frame: 4 years
4 years
Prognostic outcomes according to the central radicality
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Tokyo Medical and Dental University, Japan

Investigators

  • Study Director: Kenichi Sugihara, M.D., Ph.D, Tokyo Medical and Dental University, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2013

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimated)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRICC1410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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