Unique ID issued by UMIN | UMIN000029403 |
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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 |
Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer
BNCT on recurrent breast cancer
Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer
BNCT on recurrent breast cancer
Japan |
Post-radiotherapy, recurrent breast cancer
Breast surgery | Radiology |
Malignancy
NO
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
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
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..
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
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.
20 | years-old | <= |
75 | years-old | >= |
Female
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
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
3
1st name | |
Middle name | |
Last name | Shin-Ichi Miyatake |
Osaka Medical College
Cancer Center
Daigakumachi, 2-7, Takatsuki, Osaka, Japan
072-683-1221
neu070@osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Shin-Ichi Miyatake |
Osaka Medical College
Cancer Center
Daigakumachi, 2-7, Takatsuki, Osaka, Japan
072-683-1221
neu070@osaka-med.ac.jp
Osaka Medical College
Osaka Medical College
Other
Kyoto University Research Reactor Institute
NO
大阪医科大学(大阪府)
2017 | Year | 10 | Month | 10 | Day |
Unpublished
Preinitiation
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 10 | Month | 10 | Day |
2017 | Year | 10 | Month | 03 | Day |
2017 | Year | 10 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033600
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