Colon CancerT-REXNCT02938481
International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
An observational study of Colon Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 36 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- How many people
- 3,647 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 30 May 2013to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with colon cancer who will receive potentially curative surgery at participating institutions between 22 Jan 2015 and 22 Jan 2020.
Who may be able to join
- Histologically proven colon adenocarcinoma
- Pathological stage Ⅰ, Ⅱ or Ⅲ
- Potentially curative surgery
- Informed consent for observational data collection
Who cannot join
- Tis (mucosal cancer)
- Multiple colon cancers
- All patients with preoperative adjuvant therapy
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Japan27 sites
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8519
Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
National Canser Centre Hospital East
Chiba, Chiba, 277-8577
National Cancer Centre Central Hospital
Chuo-ku, Tokyo, 104-0045
Teikyo University Chiba Medical Center
Ichihara-shi, Chiba
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806
Takano Hospital
Kumamoto, Kumamoto, 862-0924
Kurume University School of Medicine
Kurume, Hukuoka-prefecture, 830-0011
Kyorin University School of Medicine
Mitaka, Tokyo, 181-8611
Aichi Cancer Centre Hospital
Nagoya, Aichi-ken, 464-8681
Niigata Cancer Center Hospital
Niigata, Niigata
Osaka International Cancer Institute
Osaka, Osaka, 537-8511
Shiga University of Medical Science
Ōtsu, Shiga
Keiyukai Sapporo Hospital
Sapporo, Hokkaido, 003-0027
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, 162-8666
Shizuoka Cancer Centre Hospital
Sunto-gun, Shizuoka, 411-8777
Teikyo University School of Medicine
tabashi City, Tokyo, 173-8605
National Defense Medical College
Tokorozawa, Saitama, 359-8513
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Mie University Graduate School of Medicine
Tsu, Mie-ken, 514-8507
Tochigi Cancer Center
Utsunomiya, Tochigi
Wakayama Medical University
Wakayama, Wakayama
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Saisei-kai Yokohama-shi Nanbu Hospital
Yokohama, Kanagawa, 234-0054
Yokohama-city University
Yokohama, Kanagawa, 236-0004
Kanagawa Cancer Centre Hospital
Yokohama, Kanagawa, 241-8515
Lithuania2 sites
Klaipeda University hospital
Klaipėda, Lietuva
National Cancer Institute, Lithuania
Vilnius
South Korea2 sites
Yonsei University
Seodaemun-gu, Seoul, 03722
University of Ulsan College of Medicine and Asan Medical Center
Songpa-Gu, Seoul
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
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.
Read the 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.
- Conditions
- Colon Cancer
- Keywords
- colon cancer, lymph node, extent of bowel resection
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of metastatic LNs
Measured: At the time of patient registry in
Distribution of metastatic LNs
Measured: At the time of 4 years after surgery
Secondary outcomes (2)
Prognostic outcomes according to the length of bowel resection
Measured: 4 years
Prognostic outcomes according to the central radicality
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start30 May 2013
- Primary completion31 Dec 2023
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo Medical and Dental University, Japan
- Responsible party
- Sponsor
- Investigators
- Kenichi Sugihara, M.D., Ph.D, Study director, Tokyo Medical and Dental University, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938481
- Sponsor's protocol ID
- TRICC1410
- Acronym
- T-REX
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2016
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33215206
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
- ClinicalTrials.gov ID
- NCT02938481
- Acronym / sponsor ID
- T-REX / TRICC1410
- Conditions
- Colon Cancer
- Keywords
- colon cancer, lymph node, extent of bowel resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,647 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Tokyo Medical and Dental University, Japan
- Study start
- 30 May 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with colon cancer who will receive potentially curative surgery at participating institutions between 22 Jan 2015 and 22 Jan 2020.
Key inclusion criteria (4 listed)
- Histologically proven colon adenocarcinoma
- Pathological stage Ⅰ, Ⅱ or Ⅲ
- Potentially curative surgery
- Informed consent for observational data collection
Key exclusion criteria (3 listed)
- Tis (mucosal cancer)
- Multiple colon cancers
- All patients with preoperative adjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of metastatic LNs
Time frame: At the time of patient registry in
Distribution of metastatic LNs
Time frame: At the time of 4 years after surgery
2 secondary outcomes
Prognostic outcomes according to the length of bowel resection
Time frame: 4 years
Prognostic outcomes according to the central radicality
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 33215206Shiozawa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenichi Sugihara, M.D., Ph.D study director
Tokyo Medical and Dental University, Japan
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Japan, Lithuania, South Korea, Taiwan, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of metastatic LNs (time frame: At the time of patient registry in). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.