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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006057
Receipt No. 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

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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
Email

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
Email m-hisada@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University The third department of surgery
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007170

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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