UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	BNCT clinical trial for malignant skin tumors
Title of the study (Brief title)	BNCT for malignant skin tumors
Region	Japan

Condition
Condition	malignant skin tumors
Classification by specialty	Dermatology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluation of the clinical results and establish of the optimal treatment shedule
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	advers event and clinical effect
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	BNCT
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	10 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.less than 85 years old. 2.skin tumors, which precludes adequate treatment by surgery alone. 3.patients who strongly reject standard treatment. 4.recurrent tumors after primar therapy
Key exclusion criteria	1.PS is relatively better. 2.no other severe complications 3.with distant metastasis 4.superficial tumors 5.WBC:more than 3000/mm3 6.medically or socially unsuitable for this therapy
Target sample size	20

Research contact person
Name of lead principal investigator	Junichi Hiratsuka
Organization	Kawasaki Medical School
Division name	Radiation Oncology
Address	577 Matsushima Kurashiki
TEL	086-462-1111
Email	hiratuka@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Junichi Hiratsuka
Organization	Kawasaki Medical School
Division name	Radiation Oncology
Address	577 Matsushima Kurashiki
TEL	086-462-1111
Homepage URL
Email	hiratuka@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Grant from Ministry of Education, Culture,Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 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 02 Month 07 Day
Last modified on	2018 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014513