UMIN-CTR Clinical Trial

Public title

Pilot clinical study of boron neutron capture therapy on choroidal malignant melanoma

Acronym

BNCT on choroidal malignant melanoma

Scientific Title

Pilot clinical study of boron neutron capture therapy on choroidal malignant melanoma

Scientific Title:Acronym

BNCT on choroidal malignant melanoma

Region

Japan

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

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

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).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

Cancer Center

Zip code

Address

Daigakumachi, 2-7, Takatsuki, Osaka, Japan

TEL

072-683-1221

Email

neu070@osaka-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Shin-Ichi Miyatake

Organization

Osaka Medical College

Division name

Cancer Center

Zip code

Address

Daigakumachi, 2-7, Takatsuki, Osaka, Japan

TEL

072-683-1221

Homepage URL

Email

neu070@osaka-med.ac.jp

Institute

Osaka Medical College

Institute

Department

Personal name

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Kyoto University Research Reactor Institute

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪医科大学（大阪府）

Date of disclosure of the study information

2017

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

09

Month

30

Day

Date of IRB

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

Other related information

Registered date

2017

Year

10

Month

03

Day

Last modified on

2017

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033598