jRCTs061180067已完成不适用
BNCT phaseI / II clinical trial for recurrent head and neck malignancies (BNCT for H & N malignancies)
未提供0 个研究点目标入组 40 人开始时间: 2017年9月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- -
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
- 16age old over 至 85age old under（—）
- 性别
- All
入选标准
- •With recurrence head and neck melanoma that surgical treatment is not indicated.
- •The depth of tumor, less than 6cm, and without distant metastases.
- •T/N ratio is more than 2.5 using 18F-BPA-PET.
- •KPS>= 60 percentage
- •Serum creatinine<=1.2mg/dl(male), 1.0mg/dl(female)
排除标准
- •Double cancer with disease-free period less than 3 years
- •Distant metastases
- •Active infection
- •Adverse events mere than Grade 3 induced by previous therapy
- •Tumor exposure to the skin and tumor invasion to the carotid artery
- •Severe heart complications
- •Difficulty of patient fixation for irradiation
- •White blood cell<=3000/mm3, Platelet<=100,000/mm3
- •Unsuitable patients for medical or social situation
结局指标
主要结局
-
Tumor response in 6 months after BNCT
次要结局
未报告次要终点
研究者
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