NCT07259915尚未招募不适用
Multimodal Prediction of Response to Chemoradiotherapy for Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Performance of multimodal approach to predict response to chemoradiation
研究概览
简要总结
The goal of the study lies in offering a multimodal analysis of the post-therapeutic response based on both quantitative parameters and radiomics (CT, MRI, and PET imaging), and on tumor biology, in particular the hypersensitive detection of tumor DNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient with squamous cell carcinoma of the oropharynx (cT2-cT4) or squamous cell carcinoma of the oral cavity (cT2-cT4)
- •With lymph node involvement (cN1, cN2, or cN3) (confirmation of lymph node involvement after review of imaging in CCP and without histological confirmation required)
- •Eligible for curative treatment with cisplatin-based chemoradiotherapy alone (100 mg/m2 every 3 weeks or 40 mg/m2 weekly)
- •Regardless of p16 status
- •Affiliated with or covered by a social security system
排除标准
- •Head and neck squamous cell carcinomas in other locations (salivary gland, larynx, hypopharynx, cavum, sinuses)
- •Primary squamous cell carcinoma of the lymph nodes
- •History of radiotherapy to the head and neck region
- •Radiochemotherapy not based on the use of cisplatin
- •Pregnant or breastfeeding women
- •History of invasive cancer in the last 3 years (except for Breslow melanoma less than 1 mm)
- •Contraindication to MRI, CT, or PET/CT
- •Allergy or contraindication to iodine, gadolinium, or 18F-FDG
- •Uncontrolled diabetes (fasting blood glucose greater than 12 mmol/l)
- •Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographical issues, etc.)
- •Patients under guardianship or conservatorship
- •Patients deprived of their liberty by judicial or administrative decision
- •Patients undergoing psychiatric care that renders them incapable of giving their consent
- •Patients admitted to a health or social care facility for purposes other than research
结局指标
主要结局
Performance of multimodal approach to predict response to chemoradiation
时间窗: 12 months after treatment
Estimation of the area under the curve associated with the overall performance of the combined score established by the multimodal approach (PET/CT, MRI, CT, circulating tumor DNA, lymph node tumor DNA) in the post-CRT assessment of the status of a locoregional response within 12 months after chemoradiation.
次要结局
未报告次要终点
研究者
研究点 (2)
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