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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027543
Receipt No. R000030073
Scientific Title Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies
Date of disclosure of the study information 2017/08/01
Last modified on 2018/10/24

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Basic information
Public title Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies
Acronym Clinical trial of BNCT for head and neck malignancies
Scientific Title Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies
Scientific Title:Acronym Clinical trial of BNCT for head and neck malignancies
Region
Japan

Condition
Condition Head and Neck cancers
Classification by specialty
Nephrology Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

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

Assessment
Primary outcomes tumor response
Key secondary outcomes safty

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 research 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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.With head and neck tumors that have relapsed after conventional therapies
2.Without distant metastases
3.PS is less than 2
4.Tumor to Normal tissue boron ratio is more than 2.5 using 18F-BPA-PET
5.Consent to perform BNCT
6.With the approval of the Medical Ethics Committee
Key exclusion criteria 1.with severe complications
2.medically or socially unacceptable patients
3.with pace maker
Target sample size 15

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 Research Sopport
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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 05 Month 30 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=R000030073

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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