NCT02666885已完成不适用
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- locoregional progression free survival
研究概览
简要总结
The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.
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
- •locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases
- •no contraindications for PET/MRI
- •no contraindications for radiochemotherapy
- •informed consent
- •ECOG PS 0/2
排除标准
- •Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
- •previous PET/CT
- •induction therapy
- •pregnancy or breastfeeding
研究组 & 干预措施
Integration of PET/MRI in radiotherapy
Experimental
Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
干预措施: Integration of PET/MRI in radiotherapy (Radiation)
结局指标
主要结局
locoregional progression free survival
时间窗: 2 years after primary diagnosis
15% improvement in loco-regional PFS at 2 years through integrtion of pre-operative PET/MR imaging into RT treatment planning
次要结局
- Overall survival(2 years after primary diagnosis)
- Development of a multi-parametric decision support system(after termination of recruitment and follow up up to 5 years)
- Disease free survival(2 years after primary diagnosis)
研究者
研究点 (2)
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