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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003242
Receipt No. R000003922
Scientific Title Docetaxel therapy for angiosarcoma(Stewart-Treves syndrome)
Date of disclosure of the study information 2010/02/24
Last modified on 2010/08/23

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Basic information
Public title Docetaxel therapy for angiosarcoma(Stewart-Treves syndrome)
Acronym Docetaxel for Stewart-Treves syndrome
Scientific Title Docetaxel therapy for angiosarcoma(Stewart-Treves syndrome)
Scientific Title:Acronym Docetaxel for Stewart-Treves syndrome
Region
Japan

Condition
Condition Stewart-Treves syndrome
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of docetaxele for Stewart-Treves syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes phisical examination, chest X-ray, CT scan
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 tri-weekly docetaxele
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 Patients with Stewart-Treves syndrome having (or highly suspicious of) metastases
Key exclusion criteria 1 Allergy to Docetaxele or the component
2 Infectious disease
3 Severe liver, kidney, heart, gastro-intestinal, bone marrow injury
4 Pregnant or feeding
5 Concidered not suitable for the study
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Murakami
Organization Ehime University School of Medicine
Division name Dermatology
Zip code
Address Toon city, Ehime
TEL 089-960-5350
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ehime University School of Medicine
Division name Dermatology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Dermatology
Ehime University School of Medicine
Institute
Department

Funding Source
Organization Ehime University School of Medicine
Organization
Division
Category of Funding Organization
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
2010 Year 02 Month 24 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
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 Enrolling by invitation
Date of protocol fixation
2010 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 23 Day
Last modified on
2010 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003922

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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