UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023331
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email fujisan@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.