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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
Basic information | ||
Public title | Clinical significance of micrometastasis
of stage II colorectal cancer. A prospective multicenter trial |
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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 |
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Scientific Title:Acronym | Prospective study of micrometastasis in stage II CRC (MCSGO-01) | |
Region |
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Condition | |||
Condition | Stage II colorectal cancer | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Randomization in micrometastasis positive cases
HCHU 300mg for 1 year |
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Interventions/Control_2 |
Randomization in micrometastasis positive cases No therapy |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Curatively resected Stage II colorectal cancer
With informed consent,performance status is 0-2. |
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Key exclusion criteria | simultaneous or metachrounous cancers
multiple cancer lesions |
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Target sample size | 350 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |