Clinical and Biomarker Analysis Data From a Previously Pubished Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 主要终点
- Risk factors associated with survival
研究概览
简要总结
Clinicopathological and genomic data (Next generation sequencing and IHC/CISH) in available tissues were performed in patients with nasopharyngeal carcinoma who participated in a previously conducted randomized phase II study that evaulated induction chemotherapy followed by CCRT with CCRT alone.
详细描述
The study seeks to retrospectively evaluate next generation sequencing and immunohistochemistry data/CISH data performed in all available paraffin blocks from patients with locally advanced nasopharyngeal carcinoma who participated in a previously published randomized phase II study (H 5/03). H 5/03 prospectively compared induction chemotherapy with the regimen CEP followed by concomitant chemoradiotherapy versus concomitant chemoradiotherapy.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy-proven, previously untreated WHO type I, II or III NPC;
- •age > or equal to 15 years
- •stage IIB-IVB according to the American Joint Committee on Staging of Cancer classification (AJCC 2002);
- •measurable or evaluable disease
- •no other primary tumors
- •performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group scale (ECOG)
- •adequate bone marrow, hepatic, renal and pulmonary function
- •adequate nutritional status to tolerate protocol treatment and
- •adequate mental status to follow instructions, keep appointments and provide written informed consent.
排除标准
- •Secondary malignancies
- •age< 15 years
- •ECOG PS 3-4
- •Renal, hepatic, hematologic or pulmonary insufficiency
结局指标
主要结局
Risk factors associated with survival
时间窗: 3 years
次要结局
未报告次要终点