跳至主要内容
临床试验/NCT03841175
NCT03841175已完成不适用

Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 477 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
477
试验地点
1
主要终点
Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT

研究概览

简要总结

Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.

The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.

Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.

Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.

Restaging impact on prognosis and clinical management remains poorly understood.

Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • biopsy proven HSNCC
  • written consent

排除标准

  • previous head and neck malignancy

结局指标

主要结局

Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT

时间窗: 10 years

Overall survival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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