UMIN-CTR Clinical Trial

Basic information
Public title	Oncologic outcomes of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer
Acronym	Oncologic outcome of Lap-CME with D3 for T3/T4a colorectal cancer
Scientific Title	Oncologic outcomes of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer
Scientific Title:Acronym	Oncologic outcome of Lap-CME with D3 for T3/T4a colorectal cancer
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Oncologic outcome of Laparoscopic CME with D3
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year-recurrence free survival
Key secondary outcomes	5-year overall survival

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	T3/T4a colorectal cancer R0 resection
Key exclusion criteria	synchronous malignancies, emergency surgery, appendiceal tumor, familial tumor (familial adenomatous polyposis or lynch syndrome), inflammatory bowel disease,neuroendocrine tumor, and D2 lymph node dissection
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Konishi
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	Gastroenterological Surgery
Zip code	135-8550
Address	3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Email	tkonishi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Konishi
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	Gastroenterological Surgery
Zip code	135-8550
Address	3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Homepage URL
Email	tetsuro.tominaga@nagasaki-u.ac.jp

Sponsor
Institute	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Address	3-8-31 Ariake, Koto-ku, Tokyo, Japan
Tel	+81-3-3520-0111
Email	tetsuro.tominaga@nagasaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1191
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2018 Year 07 Month 25 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	we aimed to examine the oncological safety of laparoscopic CME with D3 dissection for pT3/4a colon cancer, and to examine whether increased use of a laparoscopic approach changed the outcomes in a cohort at a comprehensive cancer center.

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046549