A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- progress free survival
研究概览
简要总结
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
详细描述
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.
The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.
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
- 是
入选标准
- •Pathology confirmed nasopharyngeal squamous cell carcinoma.
- •Aged 18 to 70 years old;
- •Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
- •Have measurable lesions on CT/MRI before treatment;
- •Treatment for the first time;
- •At least 6 months lifetime was expected;
- •Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
- •Can understand and sign the consent
- •Have follow up condition
排除标准
- •Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- •Previously treatment for cancer
- •Pregnant or breeding woman, female without contraception
- •Enrolling in other drug trials
- •Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
- •Without follow up
研究组 & 干预措施
Induction chemotherapy(IC)+IMRT
Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
干预措施: Docetaxel (Drug)
Induction chemotherapy(IC)+IMRT
Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
干预措施: Cisplatin (Drug)
Induction chemotherapy(IC)+IMRT
Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
干预措施: IMRT (Radiation)
Concurrent chemoradiotherapy(CCRT)
cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
干预措施: Cisplatin (Drug)
Concurrent chemoradiotherapy(CCRT)
cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
干预措施: IMRT (Radiation)
结局指标
主要结局
progress free survival
时间窗: 5 years
次要结局
- overall survival(5 years)
- local-regional control(5 years)
- complete response(13 weeks)
研究者
Jun-Lin Yi, MD
professor
Chinese Academy of Medical Sciences