jRCTs051180219已完成不适用
Pilot clinical study of boron neutron capture therapy on post-radiotherapy, recurrent breast cancer (BNCTonrBC)
未提供0 个研究点目标入组 3 人开始时间: 2018年8月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- Local control
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- Female
入选标准
- •Patients who are diagnosed histologically as breast cancer.
- •Patients who have the one measurable recurrent lesion at least in the previous radiation treatment field.
- •The lesions were well controlled at once by surgery or previous irradiation more than 6 months.
- •Chemotherapy (including molecular targeting agent) or hormone therapy should have been started already. Anti-HER2 agent can be stopped with more than 4 weeks interval.
- •The deepest lesion should be within 8 cm in depth in diagnostic imaging.
- •Patients should be older than 20 and younger than 75 years old at informed consent.
- •ECOG Performance Status should be 0 or
- •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, serum creatinine less than 1.2 mg/dl, albumin 3.5mg/dl or more, LDH less than 240 IU /L.
- •If there are metastatic lesions, they should be controlled well by chemotherapy and so on.
- •Written informed consent should be obtained from the patients for this clinical trial.
排除标准
- •Complication of congestive heart failure of III degree or more in NYHA
- •Patients who have 3 or more metastatic organs.
- •Patients who have uncontrollable brain or lever metastasis.
- •Pregnant woman or lactating woman
- •Patients with phenylketonuria
- •Measurable exposed skin lesion more than 5cm (excluding skin ulcer derived from metastatic skin lesion from breast cancer or derived from inflammatory breast cancer).
- •Patients who have mental illness and judged as difficult for participation of this clinical trial.
- •Patients who have infectious disease which is necessary for the treatment.
- •Pulmonary fibrosis or interstitial pneumonia.
- •Patients who have the broader lesion on the skin more than 5 cm in diameter.
- •Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons.
结局指标
主要结局
Local control
The lesions should be measured on MR or CT. If it is immpossible to measure from the images, the lesions should be measured directly on the skin periodically. The assessment of local control should be judged from RECIST v.1.1.
次要结局
- Expression of adverse events
研究者
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