Clinical trial NCT02938481: International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
Official title: International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colon Cancer
Keywords: colon cancer, lymph node, extent of bowel resection
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Tokyo Medical and Dental University, Japan
First posted: 2016-10-19
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distribution of metastatic LNs
timeFrame: At the time of patient registry in
measure: Distribution of metastatic LNs
timeFrame: At the time of 4 years after surgery
Secondary outcomes:
measure: Prognostic outcomes according to the length of bowel resection
timeFrame: 4 years
measure: Prognostic outcomes according to the central radicality
timeFrame: 4 years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bayern
city: Nagoya-city
country: Japan
facility: Aichi Cancer Centre Hospital
state: Aichi-prefecture
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
city: Chiba-city
country: Japan
facility: National Canser Centre Hospital East
state: Chiba-prefecture
city: Ichihara-shi
country: Japan
facility: Teikyo University Chiba Medical Center
state: Chiba-prefecture
city: Sapporo-city
country: Japan
facility: Keiyukai Sapporo Hospital
state: Hokkaido
city: Kurume-city
country: Japan
facility: Kurume University School of Medicine
state: Hukuoka-prefecture
city: Yokohama-city
country: Japan
facility: Saisei-kai Yokohama-shi Nanbu Hospital
state: Kanagawa-prefecture
city: Yokohama-city
country: Japan
facility: Yokohama-city University
state: Kanagawa-prefecture
city: Yokohama-city
country: Japan
facility: Kanagawa Cancer Centre Hospital
state: Kanagawa-prefecture
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Kumamoto-city
country: Japan
facility: Takano Hospital
state: Kumamoto-prefecture
city: Tsu-city
country: Japan
facility: Mie University Graduate School of Medicine
state: Mie-prefecture
city: Niigata-city
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata-prefecture
city: Osaka-city
country: Japan
facility: Osaka International Cancer Institute
state: Osaka-prefecture
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama-prefecture
city: Tokorozawa-city
country: Japan
facility: National Defense Medical College
state: Saitama-prefecture
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science
state: Shiga-prefecture
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Centre Hospital
state: Shizuoka-prefecture
city: Utsunomiya-city
country: Japan
facility: Tochigi Cancer Center
state: Tochigi-prefecture
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Centre Central Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University School of Medicine
state: Tokyo
city: Mitaka-city
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Wakayama-city
country: Japan
facility: Wakayama Medical University
state: Wakayama-prefecture
city: Yamagata-city
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata-prefecture
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University
state: Seoul
city: Songpa-Gu
country: Korea, Republic of
facility: University of Ulsan College of Medicine and Asan Medical Center
state: Seoul
city: Klaipėda
country: Lithuania
facility: Klaipeda University hospital
state: Lietuva
city: Vilnius
country: Lithuania
facility: National Cancer Institute, Lithuania
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: Tokyo Medical and Dental University, Japan
name: Kenichi Sugihara, M.D., Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.