Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 716
- 主要终点
- Overall survival rate
研究概览
简要总结
Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.
Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The sex of the subject is not limited, the age is from 18 to 70 years old;
- •Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
- •Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
- •Karnofsky score ≥ 80 points;
- •No evidence of distant metastasis;
- •Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.
排除标准
- •The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
- •Previously received immunotherapy;
- •Previously received chemotherapy;
- •Previously received radiation therapy;
- •Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
- •Evidence of distant metastases or other malignancies at the same time.
研究组 & 干预措施
IMRT plus cisplatin group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
干预措施: Intensity modulated radiotherapy (Radiation)
IMRT group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
干预措施: Intensity modulated radiotherapy (Radiation)
IMRT plus cisplatin group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall survival rate
时间窗: up to 3 years
Refers to the time from included to death due to any cause.
次要结局
未报告次要终点