Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
- •Age ≥ 18 and ≤ 65 years old.
- •Tumor staged as III/IVa (according to the 8th AJCC edition).
- •No evidence of distant metastasis (M0).
- •Satisfactory performance status: Karnofsky scale (KPS) ≥
- •Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory)
- •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.
- •Written informed consent.
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Age > 65 or <
- •Treatment with palliative intent.
- •Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
- •Pregnancy or lactation.
- •History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
研究组 & 干预措施
IC plus RT
Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.
干预措施: gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil (Drug)
IC plus RT
Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.
干预措施: IMRT (Radiation)
IC plus CCRT
Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.
干预措施: gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil (Drug)
IC plus CCRT
Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.
干预措施: IMRT and concurrent cisplatin (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: 3-year
Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
次要结局
- Overall survival(3-year)
- Number of participants with adverse events(Every week during treatment, up to 4 weeks after treatment.)
- Locoregional recurrence-free survival(3-year)
- Distant metastasis-free survival(3-year)
- Objective response rates after treatments(At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy)
研究者
Xingchen Peng
Principal Investigator
West China Hospital