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Recruitment status Main results already published
Unique ID issued by UMIN C000000185
Receipt No. R000000256
Scientific Title Clinical significance of micrometastasis of stage II colorectal cancer. A prospective multicenter trial
Date of disclosure of the study information 2006/01/01
Last modified on 2016/06/11

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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


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