A Multicenter, Randomized Controlled Phase III Clinical Trial of TPF Induction Chemotherapy Versus PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Progress-free survival(PFS)
研究概览
简要总结
Through randomized controlled phase III multicenter clinical trials, TPF induction chemotherapy vs. PF regimen adjuvant chemotherapy concurrently Radiotherapy and chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- •Clinical staged as III，IVa（according to the American Joint Committee on Cancer(AJCC) 7th edition）
- •Fertility women should ensure contraception during entry into the study.
- •Age 18-69 years old.
- •Karnofsky scale(KPS)≥
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- •Adequate renal function: creatinine clearance ≥60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent
排除标准
- •With distant metastasis.
- •who had received prior chemotherapy or radiotherapy.
- •patients have physical or mental illness, and by researchers believe that patients 4.can not be completely or fully understood in this study possible complications.
- •5.pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. 6.serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
研究组 & 干预措施
TPF+CCRT
TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: TPF+CCRT (Drug)
CCRE+PF
Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy
干预措施: CCRT+PF (Drug)
结局指标
主要结局
Progress-free survival(PFS)
时间窗: 3 years
Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
次要结局
- Incidence of acute and late toxicity(3 years)
- Overall survival(OS)(3 years)
- Distant metastasis-free survival(DMFS)(3 years)
- Overall response rate(12 weeks after completion of concurrent chemoradiotherapy)
- Locoregional failure-free survival(LRFS)(3 years)
研究者
Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Guiyang Medical University