UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer
Title of the study (Brief title)	BNCT on recurrent breast cancer
Region	Japan

Condition
Condition	Post-radiotherapy, recurrent breast cancer
Classification by specialty	Breast surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1. Clinical study of boron neutron capture therapy (BNCT) using nuclear reactor for patients with post-radiotherapy, recurrent breast cancer with the assessment of local response as primary endpoint and that of adverse events as secondary endpoint
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Local control: The lesions should be measured on MR or CT or directly on the skin periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control, based on RECIST v.1.1..
Key secondary outcomes	Expression of adverse events Evaluate adverse events and serious adverse events. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).

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	Maneuver
Interventions/Control_1	BNCT for patients with post-radiotherapy, recurrent breast cancer is applied by nuclear reactor. Lithium shield should be used during neutron irradiation to protect elements in orbit from neutron exposure. Neutron irradiation time is decided to apply 1.5 x 10+E12 n/cm2 neutron as flux on skin.
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	1. Patients who are diagnosed histologically as breast cancer 2. Patients who have the one measurable recurrent lesion at least in the previous radiation treatment field. 3. The lesions were well controlled at once by surgery or previous irradiation more than 6 monhs. 4. Chemotherapy or hormone therapy should have been started already. Anti-HER2 agent can be stopped with more than 4 weeks interval. 5. The deepest lesion should be within 8 cm in depth. 6. Patients should be older than 20 and younger than 75 years old at informed consent. 7. ECOG Performance Status should be 0 or 1. 8. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment - Leukocyte count 3,000 /microlitter or more, Hemoglobin 8.0 g/dL or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less
Key exclusion criteria	1. Complication of congestive heart failure of III degree or more in NYHA 2. Patients who have 3 or more metastatic lesions. 3. Patients who have uncontrollable brain or lever metastasis. 4. Pregnant woman or lactating woman 5. Patients with phenylketonuria 6. Patients who have mental illness and judged as difficult for participation of this clinical trial. 7. Patients who have infectious disease which is necessary for the treatment. 8. Pulmonary fibrosis or interstitial pneumonia. 9. Patients who have the broader lesion on the skin more than 5 cm in diameter. 10. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
Target sample size	3

Research contact person
Name of lead principal investigator	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Cancer Center
Address	Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL	072-683-1221
Email	neu070@osaka-med.ac.jp

Public contact
Name of contact person	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Cancer Center
Address	Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	neu070@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto University Research Reactor Institute
Name of secondary funｄer(s)

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	大阪医科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 30 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 03 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033600