UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024116 |
|---|---|
| Receipt number | R000027762 |
| Scientific Title | A retrospective analysis of regorafenib and TAS-102 for advanced or recurrent colorectal cancer |
| Date of disclosure of the study information | 2016/09/21 |
| Last modified on | 2018/09/04 09:53:50 |
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Basic information
Public title
A retrospective analysis of regorafenib and TAS-102 for advanced or recurrent colorectal
cancer
Acronym
RETAS study
Scientific Title
A retrospective analysis of regorafenib and TAS-102 for advanced or recurrent colorectal
cancer
Scientific Title:Acronym
RETAS study
Region
| Japan |
Condition
Condition
advanced or recurrent colorectal
cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively evaluated the effectiveness and safety of Regorafenib and TAS-102.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety (hematological and non-hematological adverse event)
Key secondary outcomes
Response rate
Disease control rate
Progression free survival
Overall survival
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
| 46 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Advanced or recurrent colorectal cancer patient adminisitered Regorafenib or TAS-102 in periods from March, 2013 to April, 2016 at Sapporo City General Hospital
Key exclusion criteria
The case that an image evaluation was never accomplished
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Yagisawa |
Organization
Sapporo City General Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL
080-1104-6869
yagisawa.m@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Yagisawa |
Organization
Sapporo City General Hospital
Division name
medical office
Zip code
Address
1-1, Kita 11, Nishi 13, Chuo, Sapporo, Hokkaido
TEL
011-726-2211
Homepage URL
yagisawa.m@hotmail.co.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 09 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027762
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
