A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- complete response (CR) rate
研究概览
简要总结
This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.
Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
详细描述
Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
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 nasopharyngeal carcinoma for primary treatment with radical intent
- •non-keratinizing or undifferentiated type
- •clinical stage III-IVb (UICC 7th edition)
- •age between 18-70
- •satisfactory performance status: Karnofsky scale (KPS) >
- •hemoglobin > 100g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
- •serum creatinine level < 1.6 mg/dL or creatinine clearance ≥ 60 mL/min.
- •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 ≤1.5ULN
- •patients must be informed of the investigational nature of this study and give written informed consent.
- •anticipated life span more than 6 month
排除标准
- •primary treatment with palliative intent
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases
- •pregnancy or lactation
- •history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
- •prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
- •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.
研究组 & 干预措施
1A(nedaplatin and IMRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
干预措施: nedaplatin and docetaxel (Drug)
1B(cisplatin and IMRT)
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
干预措施: cisplatin and docetaxel (Drug)
2A(nedaplatin and CRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
干预措施: nedaplatin and docetaxel (Drug)
2B((cisplatin and CRT))
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
干预措施: cisplatin and docetaxel (Drug)
结局指标
主要结局
complete response (CR) rate
时间窗: 3 months
3 months after treatment
次要结局
- Acute toxicities(2 years)
- Overall Survival(1,3,5 years)
- cost-effectiveness ratio(3 months)
研究者
Wang Rensheng
Director
Guangxi Medical University