A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 246
- 试验地点
- 12
- 主要终点
- 5-year metastatic free survival
研究概览
简要总结
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.
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
- •Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
- •According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
- •Patients who have not received disease-related anti-tumor system therapy;
- •Age 18~70 years;
- •Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
- •Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
- •Cartesian score ≥70; or ECOG PS 0 or 1
- •Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
- •Sign the informed consent.
排除标准
- •Patients with distant metastases were identified at the time of diagnosis;
- •Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
- •Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
- •Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
- •A woman who is pregnant or lactating;
- •Known active HIV or HBV, HCV infection;
- •Known to be allergic to drugs that may be used;
- •The researchers did not consider participants to be eligible for this study.
研究组 & 干预措施
4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy
Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy
干预措施: 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy (Drug)
3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy
3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy
干预措施: 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy (Drug)
结局指标
主要结局
5-year metastatic free survival
时间窗: 5 years
the duration between the date of diagnosed and date of metastasis
5-year overall survival
时间窗: 5 years
the duration between the date of diagnosed and date of patient death
次要结局
- Safety (incidence of grade 3/4 adverse reactions)(5 years)
- 5-year recurrence-free survival(5 years)
- 5-year disease-free survival(5 years)