UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006057 |
|---|---|
| Receipt number | R000007170 |
| Scientific Title | Cohort study of capecitabine plus oxaliplatin (XELOX) together with Bevacizumab as the first-line therapy in advance or recurrent colorectal cancer. |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2011/07/28 10:18:18 |
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Basic information
Public title
Cohort study of capecitabine plus oxaliplatin (XELOX) together with Bevacizumab as the first-line therapy in advance or recurrent colorectal cancer.
Acronym
Cohort study of capecitabine plus oxaliplatin (XELOX) together with Bevacizumab as the first-line therapy in advance or recurrent colorectal cancer.
Scientific Title
Cohort study of capecitabine plus oxaliplatin (XELOX) together with Bevacizumab as the first-line therapy in advance or recurrent colorectal cancer.
Scientific Title:Acronym
Cohort study of capecitabine plus oxaliplatin (XELOX) together with Bevacizumab as the first-line therapy in advance or recurrent colorectal cancer.
Region
| Japan |
Condition
Condition
Advance or recurrent colorectal cancer.
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical efficacy and safety of the combination of XELOX + Bevacizumab as a first-line therapy in patients with advanced or recurrent colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Response rate at the fourth course
Time-to-treatment failure
Overall survival
Resection rate in subjects with liver metastasis
R0 resection rate in subjects with liver metastasis
Safety
Assessment of Quality of life (Dermatology Life Quality Index)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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) Patient With estimative lesion and Histological confirmation of colorectal cancer.
(2) Patients with unresectable colorectal cancer who had received no previous therapy.
(3) Patient who is scheduled to be administered the combination of XELOX + Bevacizumab.
(4) Patient who is 20 years old or more.
(5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) : 0 - 2.
(6) Appropriate for the study at the physician's assessment.
(7) Written informed consent.
Key exclusion criteria
(1)Patient who fall under the a package insert "contraindication" or "Contraindicaton in combination" with Bevacizumab , Oxaliplatin and Capecitabine.
(2) Not appropriate for the study at the physician's assessment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Aoki |
Organization
Tokyo Medical University
Division name
The third department of surgery
Zip code
Address
6-7-1 Nishishinnjuku, Shinjuku-ku, 160-0023 Tokyo Japan
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Hisada |
Organization
Tokyo Medical University
Division name
The third department of surgery
Zip code
Address
6-7-1 Nishishinnjuku, Shinjuku-ku, 160-0023 Tokyo Japan
TEL
03-3342-6111
Homepage URL
m-hisada@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University The third department of surgery
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
東京医科大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study (Prospective observational study)
Outcome: The clinical efficacy and safety of the combination of XELOX+Bevacizumab as a first-line therapy in patients with advanced or recurrent colorectal cancer.
Management information
Registered date
| 2011 | Year | 07 | Month | 28 | Day |
Last modified on
| 2011 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007170
