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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011221
Receipt No. R000013149
Scientific Title Boron neutron capture therapy for recurrent and advanced head and neck cancer.
Date of disclosure of the study information 2013/10/01
Last modified on 2018/07/23

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Basic information
Public title Boron neutron capture therapy for recurrent and advanced head and neck cancer.
Acronym BNCT for head and neck cancer.
Scientific Title Boron neutron capture therapy for recurrent and advanced head and neck cancer.
Scientific Title:Acronym BNCT for head and neck cancer.
Region
Japan

Condition
Condition head and neck cancer.
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We determine safety and effect of treatment of Boron neutron capture therapy for recurrent and advanced head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes effective rate, local control rate
Progression-free survival
Key secondary outcomes Overall survival
Cause-specific survival

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
Interventions/Control_1 We determine safety and effect of treatment of Boron neutron capture therapy for recurrent and advanced head and neck cancer. Target tumor dose to 20 Gy - Eq or more, and make it irradiation only once.
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
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Newly diagnosed or recurrent locakky advanced head and neck cancers.
2. Age is 15 years old from 85 years old.
3. Deepest part of the tumor within 7 cm of the slin surface.
4. A tumor/normal tissue boron concentration ratio, obtained from F-BPA-PET, greater than 2.5.
5. Consent to perform BNCT from the patient and patient's family.
6. ECOG Performance Status 2 or less.
Key exclusion criteria 1. ECOG Performance Status more than 3.
2.There is serious basal disease except head and neck cancer
3. Distant metastasis lesion of the activity
4. Performed radiotherapy considerably 100 Gy or more before.
5. Phenylketonuria
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Sakurai
Organization University of Tsukuba Faculty of Medicine
Division name Radiation Oncology
Zip code
Address Amakuho2-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
TEL 029-853-7100
Email hsakurai@pmrc.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruhito Aihara
Organization Osaka Medical College
Division name Kansai BNCT Medical Center
Zip code
Address Daigakucyo2-7, Takatsuki, Osaka, Japan.
TEL 072-683-1221
Homepage URL
Email taihara@osaka-med.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2013 Year 10 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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2013 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013149

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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