UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011221 |
|---|---|
| Receipt number | 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 07:47:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
taihara@osaka-med.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013149
