UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot clinical study of boron neutron capture therapy on choroidal malignant melanoma
Title of the study (Brief title)	BNCT on choroidal malignant melanoma
Region	Japan

Condition
Condition	Treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy
Classification by specialty	Ophthalmology 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 treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy, 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: Skin lesion of angiosarcoma should be photographed and measured on it, periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control.
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 treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy 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 retina.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed as choroidal malignant melanoma with ophthalmoscopy, fluorescein funduscopy, indoceanin green fluorescence funduscopy, MRI and 123I-IMP-SPECT 2. Patients who have the primary lesion more than 16mm in diameter or have the relapsed inoperable lesion after radio-therapy. 3. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment Leukocyte count 3,000 /microlitter or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less, Total bilirubin 1.5 mg/dL or less, Serum creatinine 1.2 mg/dL or less
Key exclusion criteria	1. Patients who have systemic metastasis. 2. Pregnant woman or lactating woman 3. Patients with phenylketonuria 4. Patients who have mental illness and judged as difficult for participation of this clinical trial. 5. Patients who have the serum 5-S-CD value more than institutional reference value. 6. 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	Japan

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=R000033598