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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003416
Receipt No. R000004138
Scientific Title Cohort study of bevacizumab in combination with XELOX for metastatic colorectal cancer
Date of disclosure of the study information 2010/04/01
Last modified on 2014/04/08

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Basic information
Public title Cohort study of bevacizumab in combination with XELOX for metastatic colorectal cancer
Acronym Cohort study of bevacizumab in combination with XELOX for metastatic colorectal cancer
Scientific Title Cohort study of bevacizumab in combination with XELOX for metastatic colorectal cancer
Scientific Title:Acronym Cohort study of bevacizumab in combination with XELOX for metastatic colorectal cancer
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the drug administration situation (drug compliance situation, post-treatment, etc ) in colorectal cancer patients who receive XELOX+BV as initial therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ORR; overall response rate
drug administration situation (drug compliance situation, post-treatment, etc )
Key secondary outcomes liver resection rate
R0 liver resection rate
TTF:time to treatment-failure
PFS:progression-free survival
OS :Overall survival
adverse effects

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.colorectal cancer cytologically and or histrogically
2.bidimensionally measurable disease no prior treatment for metastatic disease
3.XELOX+BV can be treatable
4.written informed consents
Key exclusion criteria 1.Synchronous or metachronous multiple cancers
2. Contraindication of bevacizumab oxaliplatin and capecitabine
3.Investigators considers not suitable for the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Husao Ikeda
Organization West Kobe Medical Center
Division name Department of surgery
Zip code
Address 5-7-1 Kohjidai Nishi-ku Kobe-City, 651-2273,JAPAN
TEL 078-997-2200
Email fikeda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Kotaka Rieko Yoneda
Organization Sano Hospital
Division name Digestive Disease Center
Zip code
Address 2-5-1 Simizugaoka Tarumi-ku Kobe-City,655-0031,JAPAN
TEL 078-785-1000
Homepage URL
Email tomomakotaka6410@yahoo.co.jp

Sponsor
Institute Sano Hospital
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
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information ORR; overall response rate
drug administration situation (drug compliance situation, post-treatment, etc )
liver resection rate
R0 liver resection rate
TTF:time to treatment-failure
PFS:progression-free survival
OS :Overall survival
adverse effects


Management information
Registered date
2010 Year 03 Month 31 Day
Last modified on
2014 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004138

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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