UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002013 |
|---|---|
| Receipt number | R000002452 |
| Scientific Title | Biomarker-Cohort Study of Adjuvant Chemotherapy for Stage III Colon Cancer |
| Date of disclosure of the study information | 2009/05/29 |
| Last modified on | 2012/07/30 19:44:42 |
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Basic information
Public title
Biomarker-Cohort Study of Adjuvant Chemotherapy for Stage III Colon Cancer
Acronym
Biomarker-Cohort Study of Adjuvant Chemotherapy for Stage III Colon Cancer (B-CAST)
Scientific Title
Biomarker-Cohort Study of Adjuvant Chemotherapy for Stage III Colon Cancer
Scientific Title:Acronym
Biomarker-Cohort Study of Adjuvant Chemotherapy for Stage III Colon Cancer (B-CAST)
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this large observational cohort study are to identify predictive factors of efficacy and safety of adjuvant therapy of each FU drug, and investigate possibility of "personalized treatment" based on the predictive factors in adjuvant chemotherapy for stage III colon cancer.
Basic objectives2
Others
Basic objectives -Others
The tumor specimens from patients with stage III colon cancer who received adjuvant chemotherapy after curative resection are collected.
The patient data should be reviewed are as follows: treatment regimen, duration of the treatment, dosage of drugs, disease free survival(DFS), relapse free survival(RFS), overall survival(OS) and adverse effects.
Measurements of protein expression levels of TP, DPD, VEGF and EGFR, and mRNA expression levels of TP, DPD, TS and OPRT are performed.
Then, relationship between the expression levels of the enzymes and the patients data is examined.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between expression levels of the enzymes and DFS, RFS, OS and adverse effects.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Colon cancer (adenocarcinoma)
2) Curatively resected (R0)
3) Pathologically confirmed stage III
4) No preoperative chemotherapy or adjuvant radiotherapy
5) With FU-based adjuvant chemotherapy
6) Written informed consents
Key exclusion criteria
1) Synchronous or metachronous multiple cancers
2) Contraindication of FU drugs
3) The investigator considers not suitable for the study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Sugihara, M.D., PhD |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Dept. of Surgical Oncology
Zip code
Address
1-5-45, Yushima , Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-5803-5261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Sugihara, M.D., PhD |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Dept. of Surgical Oncology
Zip code
Address
1-5-45, Yushima , Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-5803-5261
Homepage URL
http://www.ibri-kobe.org/
k-sugi.srg2@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biochemical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00918827
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 29 | 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
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study (Prospective observational study).
Outcome: Relationship between expression levels of the enzymes and DFS,RFS, OS and adverse effects.
Management information
Registered date
| 2009 | Year | 05 | Month | 28 | Day |
Last modified on
| 2012 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
