The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.
详细描述
The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
- •Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
- •The metastatic lesions ≤5 and metastatic organs ≤2
- •Karnofsky scores >70
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
- •Informed consent signed.
排除标准
- •Histologically conformed initial keratinizing carcinoma or others.
- •The metastatic lesions >5 or metastatic organs >
- •Any severe complications contraindicated chemotherapy or radiotherapy.
- •History of malignant tumors.
- •Pregnant or nursing women.
- •History of radiotherapy or chemotherpy in head and neck regions.
- •Patients refused the informed consent.
研究组 & 干预措施
Arm 1
4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy.
干预措施: radical radiotherapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Events of death caused by any reasons
次要结局
- Progress free survival(From date of diagnosis until the date of first documented progression, assessed up to 36 months)