Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- FFS, Failure Free Survival
研究概览
简要总结
This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced 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
- •Age 18-65 years old;
- •Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
- •Stage T3-4N0-1 (according to the UICC/AJCC 8th);
- •No distant metastasis;
- •Have not received anti-cancer treatment in the past;
- •ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
- •Adequate hematologic, hepatic and renal function.
排除标准
- •The purpose of treatment is palliative;
- •Diagnosed with other malignant tumors at the same time;
- •Malignant tumor history;
- •Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
- •Combined serious illness.
研究组 & 干预措施
2 cycles
2 cycles induction + concurrent chemoradiotherapy
干预措施: 2 cycles induction chemotherapy (Drug)
3 cycles
3 cycles induction + concurrent chemoradiotherapy
干预措施: 3 cycles induction chemotherapy (Drug)
结局指标
主要结局
FFS, Failure Free Survival
时间窗: 3 years
Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
次要结局
未报告次要终点
研究者
Chen Yong
Prof.
First Affiliated Hospital, Sun Yat-Sen University