UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023331 |
|---|---|
| Receipt number | R000026882 |
| Scientific Title | Efficacy of Eribulin Monotherapy in Patients with Unresectable Angiosarcoma--A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/01/28 09:18:45 |
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Basic information
Public title
Efficacy of Eribulin Monotherapy in Patients with Unresectable Angiosarcoma--A Multicenter Prospective Observational Study
Acronym
Erbulin monotherapy for angiosarcoma
Scientific Title
Efficacy of Eribulin Monotherapy in Patients with Unresectable Angiosarcoma--A Multicenter Prospective Observational Study
Scientific Title:Acronym
Erbulin monotherapy for angiosarcoma
Region
| Japan |
Condition
Condition
Angiosarcoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy of eribulin in patients with unresectable angiosarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Secondary endpoint:response ratio, PFS, adverse events
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically confirmed angiosarcoma of the skin and scheduled to treat with eribulin monotherapy
2) Previous chemotherapy equal or less than 3 regimens
Key exclusion criteria
1) Severe bone marrow suppression
2) Presence of uncontrolled hemopneumothorax
3) Pregnancy or possibility of pregnancy
4) Investigator's decision
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
Unversity of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3128
fujisan@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3128
Homepage URL
fujisan@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Primary endpoint:OS
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
| 2016 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 01 | Day |
Other
Other related information
Secondary endpoint:response ratio, PFS, adverse events
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026882
