UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018935 |
|---|---|
| Receipt number | 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 21:35:24 |
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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
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
satoshi-yuuki175@joy.ocn.ne.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
