UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003961 |
|---|---|
| Receipt number | 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 11:55:02 |
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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
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
Sponsor or person
Institute
Kochi Health Sciences Center
Institute
Department
Personal name
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004771
