NCT02469922已完成不适用
Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck
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
- 130
- 试验地点
- 5
- 主要终点
- Locoregional relapse
研究概览
简要总结
Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years
- •invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology
- •locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer
- •performance status ECOG ≤
- •ECOG = Eastern Cooperative Oncology Group
- •no history of irradiation of the head and neck
- •start of radiotherapy within 8 weeks after the pretreatment PET Scan
- •no surgery other than biopsy
- •pregnancy test: negative for women of childbearing potential
- •reliable contraception for a childbearing couple, men and woman must have a reliable contraception during treatment
- •signed informed consent form
- •patient with national health insurance
排除标准
- •prior radiotherapy or chemotherapy
- •history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma
- •unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma)
- •pregnant patient or patient with breastfeeding
- •patient unable to give his consent
- •patient under administrative supervision
- •patient who participates to another clinical trial on experimental drug
- •regular follow-up impossible for various reasons (familial, economical, social, ...)
- •accelerated radiotherapy protocol
研究组 & 干预措施
Positron emission tomography
Experimental
Two additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed
干预措施: Positron emission tomography (Device)
Positron emission tomography
Experimental
Two additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed
干预措施: radiochemotherapy (Radiation)
结局指标
主要结局
Locoregional relapse
时间窗: 2 years
次要结局
- Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)(pretreatment, 15 days, 29 days, 3 months post treatment)
研究者
研究点 (5)
Loading locations...
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