NCT03087695Unknown不适用
Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.
详细描述
EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma
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
- 否
入选标准
- •Histological proven NPC.
- •2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
- •Age ≧ 20 years old.
- •Performance status of Eastern Cooperative Oncology Group (ECOG) ≦
- •Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.
- •5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.
- •Pre-treatment plasma EBV DNA > 0 copies/mL
- •Signed informed consent.
排除标准
- •Presence of distant metastasis.
- •Previous radiotherapy or chemotherapy.
- •History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
- •Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
- •Female patients who are pregnant or lactating.
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years
Survival calculation
次要结局
- EBV DNA concentration(2 years)
- Progression free survival (PFS)(2 years)
- Nasopharynx failure-free survival (NPFFS)(2 years)
- Neck failure-free survival (NFFS)(2 years)
- Distant metastasis failure-free survival (DMFFS)(2 years)
- Tumor response(2 years)
研究者
研究点 (1)
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