UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029403
Receipt number R000033600
Scientific Title Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer
Date of disclosure of the study information 2017/10/10
Last modified on 2017/10/03 16:46:03

* 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

Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer

Acronym

BNCT on recurrent breast cancer

Scientific Title

Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer

Scientific Title:Acronym

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

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


Public contact

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


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



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)



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

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


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

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name