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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008425
Receipt No. R000009910
Scientific Title Phase II study of XELIRI and High-dose bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Date of disclosure of the study information 2012/07/14
Last modified on 2012/07/13

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Basic information
Public title Phase II study of XELIRI and High-dose bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Acronym AVIRIX study
Scientific Title Phase II study of XELIRI and High-dose bevacizumab as second-line therapy in patients with metastatic colorectal cancer
Scientific Title:Acronym AVIRIX study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of High-dose bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with oxaliplatin, and bevacizumab
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes

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 XELIRI plus bevacizumab therapy
Bevacizumab 10mg/kg day1
Irinotecan 150mg/m2 day1
Capecitabin 2,000mg/m2/day day1-8
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.Histological confirmation of colorectal cancer
2.Unrecectable metastatic colorectal cancer
3.Metastatic colorectal cancer which has prior therapy of Oxliplatin-based chemotherapy with bevacizumab
4.Age over 20
5.Group(ECOG) Performance Status (PS) 0-1
6.An evaluable lesion is confirmed with objective documents such as CT,MRI within 4 weeks before registration
7.Satisfactory oral feeding
8. Have the treatment-free interval of 2-4 weeks since previous completion of treatment by a registration day
9.Vital organ functions are preserved within 2 weeks prior to entry
10.Life expectancy of more than 3 months
11. Written consent is taken
Key exclusion criteria 1.History of severe allergy
2.Pregnant or lactating women or women of childbearing potential
3.Severe infection disease
4.HBsAg(+) or HBV-DNA(+)
5.Previous history of hemoptysis or evidence of bleeding diathesis or coagulopathy
6. Metastases to the CNS
7. Complication of inflammation or active gastrointestinal
8. Non-healing wound
9. anti-platelets therapy
10. History of thrombosis or cerebrovascular disorder
11. Uncontrolled high blood pressure
12. Serious heart disease
13. Uncontrolled diarrhea
14.Paresis of intestine or intestinal obstruction
15.Interstitial pneumonitis
16.Serious peritoneal fluid and pericardial fluid
17.Multiple primary cancer which heals within five years

18. receiving atazanavir sulfate
19. requiring steroid drug
20.Have the homo and double heterozygote of *6,*28.
21. Other conditions not suitable for this study
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sotarou akatsuka
Organization Yokohama Rosai Hospital
Division name Division of Medical Oncology
Zip code
Address 3211 Kozukue-Cho;kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama Rosai Hospital
Division name Division of Medical Oncology
Zip code
Address 3211 Kozukue-Cho;kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL 045-474-8111(5147)
Homepage URL
Email sakatsuk@yokohamah.rofuku.go.jp

Sponsor
Institute Yokohama Rosai 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
2012 Year 07 Month 14 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 Preinitiation
Date of protocol fixation
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 13 Day
Last modified on
2012 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009910

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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