JPRN-jRCTs061180066已完成1 期
BNCT phase I / II trial for skin malignancies - BNCT phase I / II trial for skin malignancies
Kamitani Nobuhiko0 个研究点目标入组 3 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
The findings in our clinical trials indicate that BNCT is effective against a recurrent cancer after conventional therapies, if BPA accumulates sufficiently in the tumor.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1) With recurrent skin malignancies that surgical treatment is not indicated or is strongly rejected by patient.
- •2) The depth of tumor is less than 6cm
- •3) T/N ratio is more than 2.5 using 18F-BPA-PET.
- •4) Serum creatinine<=1.2mg/dl(male), 1.0mg/dl(female)
- •5) KPS>= 60 percentage
排除标准
- •1) Double cancer with disease-free period less than three years
- •2) Distant metastases
- •3) Active infection
- •4) Adverse events mere than Grade 3 induced by previous therapy
- •5) Severe heart complications
- •6) Difficulty of patient fixation for irradiation
- •7) White blood cell<=3000/mm3, Platelet<=100,000/mm3
- •8) Unsuitable patients for medical or social situation
研究者
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