Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.
详细描述
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Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)
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Disease status: locally advanced or recurrent/metastasized at initial presentation
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Age >=20 years old
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Could understand and signed the informed consents of this study
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Enrolled patients were classified into three distinct subgroups:
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Patients underwent curative surgery followed by adjuvant chemoradiotherapy (CRT) because of some pathologic features such as positive margin, pathologic N2, and extracapsular spread (ECS) of involved lymph nodes indicating early relapse according to recommendation from National Comprehensive Cancer Network(NCCN) guidelines;
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Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);
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Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.
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Blood samples were collected within 7 days before the first dose of chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically or cytopathologically proven head and neck squamous cell carcinoma Age ≥ 20 years. Measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
- •Ability to sign informed consent.
排除标准
- •Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
- •Inability to comply with study and/or follow-up procedures.
结局指标
主要结局
Progression-free survival
时间窗: one year
Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, PET study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
次要结局
未报告次要终点