Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- FFS
研究概览
简要总结
The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced nasopharyngeal carcinoma.
详细描述
All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Nomogram-predicted low risk patients (Group A) receive concurrent chemotherapy, while nomogram-predicted high risk patients are randomized to receive concurrent chemotherapy (Group B) or induction chemotherapy followed by concurrent chemotherapy (Group C). Induction chemotherapy consists of docetaxel 65 mg/m², D1, cisplatin 75 mg/m², D1 and Xeloda 2000mg/m², D1-14 every 3 weeks for 3 cycles. Concurrent chemotherapy consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
- •Tumor staged as III-IVb (the 2010 UICC/AJCC staging system).
- •Karnofsky scale (KPS) ≥
- •Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
- •Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
- •Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
- •Patients must give written informed consent.
排除标准
- •Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
- •Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
- •Deficient in dihydropyrimidine dehydrogenase
研究组 & 干预措施
Group A
low risk NPC treated with concurrent chemoradiotherapy
干预措施: IMRT (Radiation)
Group A
low risk NPC treated with concurrent chemoradiotherapy
干预措施: Cisplatin 2 (Drug)
Group B
high risk NPC treated with concurrent chemoradiotherapy
干预措施: IMRT (Radiation)
Group B
high risk NPC treated with concurrent chemoradiotherapy
干预措施: Cisplatin 2 (Drug)
Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
干预措施: Docetaxel (Drug)
Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
干预措施: Cisplatin 1 (Drug)
Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
干预措施: Xeloda (Drug)
Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
干预措施: IMRT (Radiation)
Group C
high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
干预措施: Cisplatin 2 (Drug)
结局指标
主要结局
FFS
时间窗: 2 years
次要结局
未报告次要终点
研究者
Fang-Yun Xie
Prof.
Sun Yat-sen University