UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chemoradiation followed by maintenance therapy for patients with locally advanced cutaneous angiosarcoma
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuhiro Fujisawa
Organization	University of Tsukuba
Division name	Dermatology
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3128
Email	fujisan@md.tsukuba.ac.jp

Public contact
Name of contact person	Yasuhiro Fujisawa
Organization	University of Tsukuba
Division name	Dermatology
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3128
Homepage URL
Email	fujisan@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016752