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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018935
Receipt No. R000021908
Scientific Title Observational Cohort Study of First line Bevacizumab with Oxaliplatin or Irinotecan and Fluoropyrimidines in Metastatic Colorectal Cancer
Date of disclosure of the study information 2015/09/08
Last modified on 2017/03/15

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Basic information
Public title Observational Cohort Study of First line Bevacizumab with Oxaliplatin or Irinotecan and Fluoropyrimidines in Metastatic Colorectal Cancer
Acronym HGCSG0802
Scientific Title Observational Cohort Study of First line Bevacizumab with Oxaliplatin or Irinotecan and Fluoropyrimidines in Metastatic Colorectal Cancer
Scientific Title:Acronym HGCSG0802
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness and safety of bevacizumab combined with standard chemotherapy regimens for patients with metastatic 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 Safety, Overall survival, Time to treatment failure, Response rate

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)Histologically confirmed metastatic colorectal cancer (mCRC)
2)No history of chemotherapy or radiotherapy for mCRC (No progression within 6 months of adjuvant therapy completion (if received))
3)Measurable disease according to RECIST 1.0
4)Age of 20 years or older
5)ECOG PS 0-2
6)Life expectancy of longer than 3 months
Key exclusion criteria 1)Major surgical procedure within 28 days before enrollment
2)Gastrointestinal perforation in the previous 1 year
3)Thromboembolic events in the previous 1 year
4)Uncontrolled hypertension
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address Kita-14. Nishi-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yuki
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address Kita-14. Nishi-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Homepage URL
Email satoshi-yuuki175@joy.ocn.ne.jp

Sponsor
Institute NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 09 Month 08 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 Main results already published
Date of protocol fixation
2008 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 11 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 01 Day
Date trial data considered complete
2016 Year 05 Month 01 Day
Date analysis concluded
2017 Year 04 Month 01 Day

Other
Other related information Study Design : Prospective cohort study
Patients : Between November-2008, and September-2012, we enrolled eligible patients with metastatic colorectal cancer for whom first line bevacizumab combined chemotherapy were initiated at the participating institutions.
Outcome : Safety, Overall survival, Progression-free survival, Time to treatment failure, Response rate, and R0 resection rate.

Management information
Registered date
2015 Year 09 Month 08 Day
Last modified on
2017 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021908

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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