Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)
研究概览
简要总结
The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
详细描述
Scheme:
Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
- Arm nimotuzumab:
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
- •Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
- •Stage III and IVA/B NPC patients
- •Age between 18-70
- •AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min
排除标准
- •Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
- •Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- •Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- •Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
- •Prior radiation treatment to the head and neck or any prior chemotherapy
研究组 & 干预措施
Arm Cisplatin
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
干预措施: TPF neoadjuvant chemotherapy (Drug)
Arm Cisplatin
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
干预措施: Concurrent chemotherapy with cisplatin during radiotherapy (Drug)
Arm Cisplatin
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
干预措施: Radical radiotherapy (Radiation)
Arm Nimotuzumab
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
干预措施: TPF neoadjuvant chemotherapy (Drug)
Arm Nimotuzumab
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
干预措施: Concurrent nimotuzumab during radiotherapy (Drug)
Arm Nimotuzumab
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
干预措施: Radical radiotherapy (Radiation)
结局指标
主要结局
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)
时间窗: From Day 1 to Day 90 of radiotherapy
次要结局
- PFS(3 years)
- OS(3 years)