NCT02111460Unknown3 期
Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The patients with initial untreated metastatic nasopharyngeal carcinoma
- •Histologic diagnosis of nasopharyngeal carcinoma
- •T1-4N0-3M1,IVC(according to the 7th AJCC edition)
- •Aged between 18 and 65 years
- •The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
- •Voluntary to participate and sign informed consent document
排除标准
- •The patients suffered from serious neurologic disease
- •Clinically significant cardiac, heart function less than or equal to 3 level
- •Clinically significant respiratory disease,lung function less than or equal to 3 level
- •Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L
- •Abnormal liver function: total bilirubin or ALT or AST>2×ULN
- •Abnormal renal function:serum creatinine>1.5×ULN
- •Pregnant or lactating women
- •The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
结局指标
主要结局
Overall survival
时间窗: 2 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
次要结局
- Progress-free survival(2 years)
- Complete Response (CR)(after the completion of the chemoradiotherapy treatment (up to 9 weeks))
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and ChemotherapyNasopharyngeal CarcinomaNCT05622474Sun Yat-sen University236
尚未招募
2 期
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous CarcinomaHead and Neck Squamous CarcinomaNCT05039606Guiyang Medical University164
已完成
3 期
Radiotherapy or Imiquimod in Complex Lentigo MalignaLentigo MalignaNCT02394132Melanoma and Skin Cancer Trials Limited126
招募中
3 期
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal CarcinomaRadiotherapyChemotherapyNasopharyngeal CarcinomaNCT04448522Sun Yat-sen University508
进行中（未招募）
3 期
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial CarcinomaEndometrial NeoplasmsNCT01820858Ding Ma300