UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014397 |
|---|---|
| Receipt number | R000016752 |
| Scientific Title | Chemoradiation followed by maintenance therapy for patients with locally advanced cutaneous angiosarcoma |
| Date of disclosure of the study information | 2014/07/10 |
| Last modified on | 2016/06/29 08:14:08 |
* 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
Chemoradiation followed by maintenance therapy for patients with locally advanced cutaneous angiosarcoma
Acronym
chemoradiation and maintenance therapy for angiosarcoma
Scientific Title
Chemoradiation followed by maintenance therapy for patients with locally advanced cutaneous angiosarcoma
Scientific Title:Acronym
chemoradiation and maintenance therapy for angiosarcoma
Region
| Japan |
Condition
Condition
Cutaneous angiosarcoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigate the efficacy and safety of chemoradiation using paclitaxel for patients with cutaneous angiosarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
response ratio, duration of response, time to progression, adverse effect, time to distant metastasis, overall survival time, tumor-specific survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemoradiation+Maintenance therapy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cutaneous angiosarcoma of the head and neck resion/PS 0 or 1
Key exclusion criteria
PS 2 or 3/metastasis/prior therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1 Tennodai, Tsukuba
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
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
University of Tsukuba
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
| 2014 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016752
