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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003961
Receipt No. R000004771
Scientific Title XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Date of disclosure of the study information 2010/07/28
Last modified on 2011/08/01

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Basic information
Public title XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Acronym XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Scientific Title XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Scientific Title:Acronym XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Region
Japan

Condition
Condition advanced and recurrent colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy, safety of XELOX for patients can't continue continuous infusion therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes FOLFOX(+bevacizumab) from PFS
Key secondary outcomes safety,cycle number of XELOX,Quolity of life(FACT-C)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1000mg/m2 of oral Xeloda twice daily on days 1 through 14 every 3 weeks.
L-OHP 130mg/m2 is administered intravenous injection on day 1.
(Bevacizumab 7.5mg/kg is administered intravenous injection on day 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Pathologically proved colorectal cancer
2)Age at registration is above 20
3)ECOG Performance status is 0 or 1
4)FOLFOX in treatment(or at least SD)but problems such as continuous infusion of impossible to continue treating patients, Identified as difficult cases at the request of the patient continuous infusion
5)Intake of normal diet and oral drugs is possible
6)With advanced or recurrent measurable disease,colon or rectal cancer
7)At least two cycles or XELOX(+bevacizumab)treatment for possible
8)Written informed consent is taken

Key exclusion criteria 1)severe renal failure
2)severe hypersensitivity to have a history fluorouracil,lebohorinatokarushiumu, platinum, bevacizumab
3)activity with multiple cancers(After which no more than five years of activity)
4)brain metastases(only when using bevacizumab)
5)FOLFOX(+bevacizumab)treatment for 3 or more months after
6)In addition, if deemed unsuitable to participate in this study is the responsible physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kochi Health Sciences Center
Division name Department of Medical Oncology
Zip code
Address 2125-1 Ike, Kochi-city,Kochi,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Tsuji
Organization Kochi Health Sciences Center
Division name Department of Medical Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kochi Health Sciences Center
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 07 Month 28 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 Completed
Date of protocol fixation
2010 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 28 Day
Last modified on
2011 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004771

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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