UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029403
Receipt No. 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

* 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
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)

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
URL(English) https://upload.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


Contact us.