Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
This is a prospective platform study that will investigate the outcomes of patients with locoregionally-advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) who are assigned to treatment arms of different chemotherapy sequencing and intensity based on their pre- and on-treatment plasma EBV DNA results.
详细描述
The primary objectives of this platform are: (1) to prospectively validate the prognostic potential of an EBV DNA-based risk-stratification strategy of patients with LA- and RM-NPC; and (2) to test if treatment individualization strategies based on pre- and on-treatment plasma EBV DNA will improve survival outcomes. Primary study end-point is 2-year disease-free survival (DFS).
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients ≥21 years of age with any of the following:
- •Suspected NPC cases, diagnosed clinically based on symptoms (neck swelling, unilateral epistaxis, nasal obstruction etc.)
- •Newly-diagnosed, histologically confirmed NPC patients with Stages 2-4A disease based on the AJCC/UICC 8th Edition TNM stage classification
- •Newly-diagnosed patients with RM-NPC
排除标准
- •All patients <21 years or >99 years old will be excluded from participation.
结局指标
主要结局
Disease-Free Survival
时间窗: 2 years from end of treatment
次要结局
- Overall survival(2 years after end of treatment)
- Distant metastasis-free survival(2 years after end of treatment)
- Loco-regional recurrence-free survival(2 years after end of treatment)
- Treatment-related adverse events(From start of treatment to 30 days after last treatment and up to 5 years post - treatment)
- Genome sequencing of biological samples(baseline, mid/post IC, mid CCRT, 1-2 weeks post-RT, 3 months post-RT/mid-adjuvant chemotherapy, at point of recurrence and post immune checkpoint blockade treatment (for recurrence, if any) up to 5 years)