NCT02938481

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
7 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

10.6 years

First QC Date

October 17, 2016

Last Update Submit

January 27, 2026

Conditions

Keywords

colon cancer, lymph node, extent of bowel resection

Outcome Measures

Primary Outcomes (2)

  • Distribution of metastatic LNs

    At the time of patient registry in

  • Distribution of metastatic LNs

    At the time of 4 years after surgery

Secondary Outcomes (2)

  • Prognostic outcomes according to the length of bowel resection

    4 years

  • Prognostic outcomes according to the central radicality

    4 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Aichi Cancer Centre Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Canser Centre Hospital East

Chiba, Chiba, 277-8577, Japan

Location

Teikyo University Chiba Medical Center

Ichihara-shi, Chiba, Japan

Location

Keiyukai Sapporo Hospital

Sapporo, Hokkaido, 003-0027, Japan

Location

Kurume University School of Medicine

Kurume, Hukuoka-prefecture, 830-0011, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Saisei-kai Yokohama-shi Nanbu Hospital

Yokohama, Kanagawa, 234-0054, Japan

Location

Yokohama-city University

Yokohama, Kanagawa, 236-0004, Japan

Location

Kanagawa Cancer Centre Hospital

Yokohama, Kanagawa, 241-8515, Japan

Location

Takano Hospital

Kumamoto, Kumamoto, 862-0924, Japan

Location

Mie University Graduate School of Medicine

Tsu, Mie-ken, 514-8507, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 537-8511, Japan

Location

Saitama Cancer Center

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Defense Medical College

Tokorozawa, Saitama, 359-8513, Japan

Location

Shiga University of Medical Science

Ōtsu, Shiga, Japan

Location

Shizuoka Cancer Centre Hospital

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

Location

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

National Cancer Centre Central Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Teikyo University School of Medicine

Itabashi-ku, Tokyo, 173-8605, Japan

Location

Kyorin University School of Medicine

Mitaka, Tokyo, 181-8611, Japan

Location

Tokyo Women's Medical University

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Wakayama Medical University

Wakayama, Wakayama, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata, Yamagata, 990-2292, Japan

Location

Klaipeda University hospital

Klaipėda, Lietuva, Lithuania

Location

National Cancer Institute, Lithuania

Vilnius, Lithuania

Location

I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

Yonsei University

Seodaemun-gu, Seoul, 03722, South Korea

Location

University of Ulsan College of Medicine and Asan Medical Center

Songpa-Gu, Seoul, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (1)

  • Shiozawa M, Ueno H, Shiomi A, Kim NK, Kim JC, Tsarkov P, Grutzmann R, Dulskas A, Liang JT, Samalavicius N, West N, Sugihara K. Study protocol for an International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer (T-REX study). Jpn J Clin Oncol. 2021 Jan 1;51(1):145-155. doi: 10.1093/jjco/hyaa115.

Biospecimen

Retention: SAMPLES WITH DNA

* Resected surgical specimens to take photographs * Lymph nodes retrieved from Resected surgical specimens to categorise

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Kenichi Sugihara, M.D., Ph.D

    Tokyo Medical and Dental University, Japan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

May 30, 2013

Primary Completion

December 31, 2023

Study Completion

January 31, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations