Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Loco regional control
研究概览
简要总结
The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.
详细描述
Patients with squamous cell carcinoma of the head & neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters.
The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
- •The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
- •The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
- •The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate
排除标准
- •The patient is unwilling to participate in the study
- •Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
- •Pregnancy or lactation
- •Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
- •Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m
- •Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
结局指标
主要结局
Loco regional control
时间窗: 2 years
After completion of radiotherapy
次要结局
- Patterns of failure(2 years)
- Site specific toxicity(1 year)
- Loco regional tumour control (response)(2 months)
- Overall survival(5 years)
- Changes in imaging and metabolic data(1-2 weeks)