Oct. 07, 2022 |
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May. 02, 2024 |
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jRCTs031220371 |
Pilot study of Boron Neutron Capture Therapy for recurrent breast cancer after radiotherapy |
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Study of BNCT on recurrent breast cancer |
Kurosaki Hiromasa |
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Edogawa Hospital |
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2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan |
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+81-3-3673-1221 |
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h.kurosaki@edogawa.or.jp |
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Kurosaki Hiromasa |
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Edogawa Hospital |
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2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan |
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+81-3-3673-1221 |
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h.kurosaki@edogawa.or.jp |
Recruiting |
Oct. 07, 2022 |
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June. 27, 2023 | ||
5 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) Written consent for participation in this study has been obtained from the subject or a surrogate at the time consent is obtained. |
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1) Patients who have received more than 75 Gy of radiotherapy to the lesion area in the prior treatment of the target lesion. |
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18age 0month 0week old over | ||
85age 0month 0week old not | ||
Both |
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breast cancer |
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Boron Neutron Capture Therapy |
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breast cancer |
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D001943 |
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Safety: Acute adverse events for safety evaluation criteria |
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Efficacy: response rate, tumor shrinkage rate, progression-free survival, overall survival |
National Institutes for Quantum Science and Technology Certified Review Board | |
4-9-1 Anagawa Inage-ku Chiba-shi, Chiba | |
+81-43-206-4706 |
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helsinki@qst.go.jp | |
Approval | |
Yes |
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De-identified (anonymized) or coded (pseudonymized) individual clinical trial participant data will be provided to CICS Co., Ltd. and Stella Pharma Co., Ltd. De-identified (anonymized) or coded (pseudonymized) individual clinical trial participant data would be shared when needed, upon request from a third party (including domestic/oversea person/organization/company), authorized by the principal investigator of this study(or another person/organization/company licensed by the principal investigator). |
none |