UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of micrometastasis of stage II colorectal cancer. A prospective multicenter trial
Acronym	Prospective study of micrometastasis in stage II CRC (MCSGO-01)
Scientific Title	Clinical significance of micrometastasis of stage II colorectal cancer. A prospective multicenter trial
Scientific Title:Acronym	Prospective study of micrometastasis in stage II CRC (MCSGO-01)
Region	Japan

Condition
Condition	Stage II colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate clinical significance of micrometastasis in lymph nodes of stage II colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	To investigate efficacy of HCFU(oral 5-FU derivatives) in micrometastasis-positive stage II colorectal cancer patients.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	3 year-disease free survival when stratified by presense or absence of micrometastasis
Key secondary outcomes	5 year-overall survival when stratified by presense or absence of micrometastasis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Randomization in micrometastasis positive cases HCHU 300mg for 1 year
Interventions/Control_2	Randomization in micrometastasis positive cases No therapy
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Curatively resected Stage II colorectal cancer With informed consent,performance status is 0-2.
Key exclusion criteria	simultaneous or metachrounous cancers multiple cancer lesions
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morito Monden
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Surgery
Zip code
Address	Department of Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita-City, Osaka 565-0871, Japan
TEL	0668793251
Email	hyamamoto@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hirofumi Yamamoto
Organization	MCSGO(Multicenter Clinical Study Group of Osaka, Colorectal Cancer Division)
Division name	Coordinating Office
Zip code
Address	Yamadaoka 2-2, Suita city, Osaka
TEL	06-6879-3251
Homepage URL
Email	hyamamoto@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	MCSGO(Multicenter Clinical Study Group of Osaka, Colorectal Cancer Division)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2006 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Micrometastasis volume measured by CEA mRNA determines disease recurrence rate in stage II colorectal cancer.
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	Main results already published
Date of protocol fixation	2001 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2001 Year 11 Month 01 Day
Last follow-up date	2008 Year 03 Month 01 Day
Date of closure to data entry	2008 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded	2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2016 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000256

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.