2024-516178-31-00招募中3 期
DAHANCA 30 Et randomiseret non-inferiority studie af hypoxi-profilvejledt nimorazolbehandling i forbindelse med primær strålebehand-ling af planocellulære hoved-halskarcinomer
Region Midtjylland9 个研究点 分布在 2 个国家目标入组 1,262 人开始时间: 2024年11月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,262
- 试验地点
- 9
- 主要终点
- Locoregional control after radiotherapy (not including possible salvage treatment).
研究概览
简要总结
To show comparable treatment response in a group of head and neck cancer patients predicted as non-responders to the hypoxic modifier nimorazol with a hypoxia gene profile, when these patients where randomized to concommitant nimorazole or not.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with HNSCC tumors where, in accordance with DAHANCA's guidelines, hypoxic modification with nimorazole under primary radiotherapy is indicated. • In addition; a) No concurrent or earlier malignant diseases that can affect the treatment, evaluation and outcome of the actual disease b) Informed consent in accordance with regulations c) Radiotherapy planned to start within 3 weeks from inclusion d) Hypoxic status from gene profile testing must be available no later than by the initiation of radiotherapy.
排除标准
- •Concurrent or previous malignant disease, enrollement in a competing trial, pregnancy or breast feeding.
结局指标
主要结局
Locoregional control after radiotherapy (not including possible salvage treatment).
Locoregional control after radiotherapy (not including possible salvage treatment).
次要结局
- Local control (T-site), regional control (N-site), distant metastases, locoregional control after salvage treatment, overall survival (survival, disease- free survival, disease-specific survival), acute or late morbidity
研究者
Kasper Toustrup
Scientific
Region Midtjylland
研究点 (9)
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