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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010200
Receipt No. R000011947
Scientific Title Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer
Date of disclosure of the study information 2013/03/11
Last modified on 2013/03/09

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Basic information
Public title Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer
Acronym Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer
Scientific Title Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer
Scientific Title:Acronym Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer
Region
Japan

Condition
Condition advanced and/or recurrent colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of Capecitabine plus bevacizumab in elderly patients with advanced and recurrent colorectal cancer as first-line chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Overall Survival,Response rate,Disease Contorol Rate,Safty

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 Capecitabine plus bevacizumab therapy
Capecitabine:2,000mg/m2 twice daily (orally, day1 after dinner:day8 after breakfast)
Bevacizumab:7.5mg/kg day 1
The treatment is repeated every three weeks until disease progression or severe toxicity.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)histologically confirmed colorectal cancer
(2)Advanced or recurrent colorectal cancer that is first line chemotherapy
(3)Age of 70 years or older
(4)Measurable or evaluable disease (RECIST ver.1.1.)
(5)ECOG performance status of 0-2
(6)Life expectancy more than 3 months
(7)Adequate organ functions
Neutrophil: => 1500/mm3
Platelet: => 100,000/mm3
Hemoglobin concentration: => 9.0g/dl
Total bilirubin: <= 1.5mg/dl
AST or ALT: <= 100IU/I
Cr: <= 1.2mg/dl
proteinuria: <= 1+
(8) Written informed consent after the explanation of the content of the examination
Key exclusion criteria (1)active brain metastases
(2) Complication of cerebrovascular disease or symptoms within 1 year
(3) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week
(4) History of gastrointestinal perforation within 1 year.
(5) Uncontrollable peptic ulcer, Hypertension, diarrhea, infections
(6) A bleeding tendency, coagulation disorder or abnormal coagulation factor
(7) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day)
(8) Serious heart disease
(9) History of active double cancer within 5 years
(10)History of the serious hypersensitivity for capecitabine or bevacizumab
(11)Other conditions not suitable for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Yamafuchi University
Division name Medical Bioregulation Department of Organ Regulatory Surgery
Zip code
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
TEL 0836-22-2260
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadahiko Enoki
Organization Yamafuchi University
Division name Medical Bioregulation Department of Organ Regulatory Surgery
Zip code
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute Yamafuchi University
Medical Bioregulation Department of Organ Regulatory Surgery
Institute
Department

Funding Source
Organization Yamafuchi University
Medical Bioregulation Department of Organ Regulatory Surgery
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
2013 Year 03 Month 11 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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 07 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 09 Day
Last modified on
2013 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011947

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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