JPRN-jRCTs061180067已完成1 期
BNCT phaseI / II clinical trial for recurrent head and neck malignancies - BNCT for H & N malignancies
Kamitani Nobuhiko0 个研究点目标入组 21 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
- 21
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 <= 85age old（—）
- 性别
- All
入选标准
- •1) With recurrence head and neck melanoma that surgical treatment is not indicated.
- •2) The depth of tumor, less than 6cm, and without distant metastases.
- •3) T/N ratio is more than 2.5 using 18F-BPA-PET.
- •4) KPS>= 60 percentage
- •5) Serum creatinine<=1.2mg/dl(male), 1.0mg/dl(female)
排除标准
- •1) Double cancer with disease-free period less than 3 years
- •2) Distant metastases
- •3) Active infection
- •4) Adverse events mere than Grade 3 induced by previous therapy
- •5) Tumor exposure to the skin and tumor invasion to the carotid artery
- •6) Severe heart complications
- •7) Difficulty of patient fixation for irradiation
- •8) White blood cell<=3000/mm3, Platelet<=100,000/mm3
- •9) Unsuitable patients for medical or social situation
研究者
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