UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of boron neutron capture therapy utilizing research reactor for skin malignant tumors
Acronym	Clinical trial of skin malignancy BNCT
Scientific Title	Clinical trial of boron neutron capture therapy utilizing research reactor for skin malignant tumors
Scientific Title:Acronym	Clinical trial of skin malignancy BNCT
Region	Japan

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

Objectives
Narrative objectives1	effectiveness
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	tumor response rate and adverse events 6 months after BNCT
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 Device,equipment
Interventions/Control_1	BPA is administrated as boron carrier and reactor is utilized as neutron source.
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	16 years-old <=
Age-upper limit	89 years-old >=
Gender	Male and Female
Key inclusion criteria	1.skin tumors that have relapsed after conventional therapies 2.inoperable skin malignant tumors 3.Without distant metastases 4.PS: less than 2 5.Consent to perform BNCT 6.With the approval of the Medical Ethics Committee 7.Japanese at the age of 16 to 89
Key exclusion criteria	1.with severe complications or double cancers 2.first therapy induced more than Grade 3 side effect 3.medically or socially unacceptable patients
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junichi Hiratsuka
Organization	Kawasaki Medical School
Division name	Radiation Oncology
Zip code
Address	577 Matsushima, Kurashiki city
TEL	086-462-1111
Email	hiratuka@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kawanishi
Organization	Kawasaki Medical School
Division name	Division of Reseach Support
Zip code
Address	577 Matsushima, Kurashiki city
TEL	086-462-1111
Homepage URL
Email	kenkyu-idai@med.kawasaki-m.ac.jp

Sponsor
Institute	kawasaki Medical School
Institute
Department

Funding Source
Organization	Japanese Government
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 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
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	Terminated
Date of protocol fixation	2017 Year 05 Month 27 Day
Date of IRB	2017 Year 08 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2020 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031573