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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002013
Receipt No. 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

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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
Email

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/
Email k-sugi.srg2@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002452

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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