UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004896 |
|---|---|
| Receipt number | R000005716 |
| Scientific Title | Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab |
| Date of disclosure of the study information | 2011/01/18 |
| Last modified on | 2017/01/25 14:43:17 |
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Basic information
Public title
Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Acronym
Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Scientific Title
Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Scientific Title:Acronym
Cohort study of Patients with metastatic colorectal cancer Treated by XELOX with bevacizumab
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate efficacy and safety of XELOX+bevacizumab therapy as first-line chemotherapy in clinical practice for patients with advanced or metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frequency and Degree of Hand-foot symdrome(HFS),Neuropathy and Vascular disorders
Key secondary outcomes
Time To Failure,
Disease Free Survival,
Overall Survival,
Overall Response Rate,
Frequency and Degree of Adverse Events Except HFS,Neuropathy and Vascular disorders.
Resection Rate of Liver Metastases,
Rate of R0 Resection of Liver Metastases
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
1)Capecitabine at a dose of 2,000mg/m2/day orally in 2 divided doses for 2weeks on and 1week rest
2) tri-Weekly oxaliplatin at a dose of 130mg/m2 intravenously
3) tri-weekly bevacizumab at a dose of 5mg/kg intravenously
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. 20 years or older
2.Histologically confirmed colorectal cancer
3.With target lesion by RECIST ver.1.1
4.Unrecetable recurrent or metastatic colorectal cancer.Not be administered any therapies except radio therapy when primary disease or primary recurrence and not be administered any therapy for reccurent tumor
5.Patients who can take food orally
6. Patients who will be administered the therapy of XELOX+Bevacizumab
7.Written IC
Key exclusion criteria
1. Prior or synchronous invasive malignancy unless disease free for a minimum of 5 years
2.Previous history of severe drug-induced allergy caused by capecitabine
3.Be Administered or less than 7 days finished administration Compound Drug of tegafur,gimeracil and oteracil potassium
4.Severe kidney trouble
5.Previous history of severe drug-induced allergy caused by oxaliplatin
6. Neuropathy or sensory dysfunction
7.Previous history of severe drug-induced allergy caused by bevacizumab
8.Pregnant women who are capable of pregnancy or intend to get pregnant
9.Patients judged inappropriate for this study by the physicians
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikinori Sato |
Organization
Gamagori City Hospital
Division name
Surgery
Zip code
Address
1-1, Mukaida, Hiratacho, Gamagori-city, Aichi-pref. Japan
TEL
0533-66-2295
sato-mikinori@gamahp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikinori Sato, Masayasu Hara |
Organization
Nagoya City University
Division name
Gastrointestinal Surgery
Zip code
Address
1, Kawasumi, Mizuhocho, Mizuho-ku, Nagoya-city,Aichi-pref. Japan
TEL
052-853-8226
Homepage URL
mshara@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Gastrointestinal 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
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
| 2011 | Year | 01 | Month | 18 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | 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
| 2011 | Year | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005716
