GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- progress-free survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.
详细描述
Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free survival (LRRFS), initial response rates after treatments, toxic effects and quality of life (QoL).
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
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition）
- •Male and no pregnant female
- •Age between 18-65
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- •Adequate renal function: creatinine clearance ≥60 ml/min
- •Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Evidence of relapse or distant metastasis
- •History of prior malignancy or previous treatment for NPC
- •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.
- •Pregnancy or lactation
研究组 & 干预措施
gemcitabine and cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: gemcitabine and cisplatin (Drug)
gemcitabine and cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: IMRT (Radiation)
gemcitabine and cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: cisplatin (Drug)
cisplatin and fluorouracil
Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: cisplatin and fluorouracil (Drug)
cisplatin and fluorouracil
Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: IMRT (Radiation)
cisplatin and fluorouracil
Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
干预措施: cisplatin (Drug)
结局指标
主要结局
progress-free survival (PFS)
时间窗: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
次要结局
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Overall Survival (OS)(3 years)
- Locoregional Relapse-Free Survival (LRRFS)(3 years)
- Number of participants with adverse events(up to 3 years)
研究者
Ming-Yuan Chen
Principal Investigator
Sun Yat-sen University