Pilot study of Boron Neutron Capture Therapy for recurrent breast cancer after radiotherapy

Kurosaki Hiromasa0 个研究点目标入组 5 人开始时间: 2022年10月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Written consent for participation in this study has been obtained from the subject or a surrogate at the time consent is obtained.
•2) The following patients with breast cancer
•Patients with confirmed recurrence within or at the margins of the chest radiotherapy field and one or more measurable lesions according to RECIST guidelines (version 1.1)
•Patients who have undergone radiotherapy for more than 6 months since their last radiotherapy treatment.
•Patients who are not adversely affected by withdrawal of chemotherapy (including molecular-targeted agents) for more than 4 weeks prior to BNCT treatment.
•Patients who are deemed capable of containing all active lesions within the irradiated area envisaged by BNCT
•Patients with the longest diameter of the entire target lesion of 15 cm or less
•Patients with lesions with a distance of 6 cm or less from the skin surface to the deepest part of the tumor
•Patients with no evidence of serious cardiac complications on resting 12-lead ECG

•1) Patients who have received more than 75 Gy of radiotherapy to the lesion area in the prior treatment of the target lesion.
•2) Patients with active lesions/active overlapping cancers other than the target lesion (however, patients with distant metastases who show no tendency to enlarge and whose quality of life can be significantly improved by controlling locally recurrent lesions are not excluded)
•3) Patients with measurable tumor skin exposure greater than 5 cm
•4) Patients with NYHA cardiac function classification grade III or IV
•5) Patients with pulmonary fibrosis or interstitial pneumonia

发起方

Kurosaki Hiromasa