UMIN-CTR Clinical Trial

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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