NCT03238378招募中不适用
SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年3月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Late side effects
研究概览
简要总结
The aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed recurrent carcinoma of the head and neck region
- •Stage rcT1-3
- •Tumor anatomy and location suitable for brachytherapy techniques.
- •cN0/pN0 or rpN+ & R0 with <3 pos. LND & without invasion of capsula.
- •Previous radiation therapy up to at least 50 Gy
- •Previous radiation therapy completed more than 6 months ago
- •Written study-specific informed consent
排除标准
- •rpN+ with >2 pos. LND or invasion of capsula
- •Pregnant or lactating women
- •Collagen vascular disease
- •The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
- •Psychiatric disorders
研究组 & 干预措施
Therapy
Experimental
Brachytherapy d1-5(6) Hyperthermia d2 + 5
干预措施: Hyperthermia (Other)
Therapy
Experimental
Brachytherapy d1-5(6) Hyperthermia d2 + 5
干预措施: Brachytherapy (Radiation)
结局指标
主要结局
Late side effects
时间窗: Effects are followed up to 5 years after therapy
Comparison late side effects to standard therapy
次要结局
- Quality of life(up to 5 years after therapy)
- Rate of local recurrencies(up to 5 years after therapy)
- Overall survival(up to 5 years after therapy)
研究者
Vratislav Strnad
Head of the Interstitial Brachytherapy at the Dept. of Radiooncology
University of Erlangen-Nürnberg Medical School
研究点 (2)
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