UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000185 |
|---|---|
| Receipt number | 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 11:29:05 |
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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
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
hyamamoto@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
MCSGO(Multicenter Clinical Study Group of Osaka, Colorectal Cancer Division)
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
