Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed written informed consent
- •Inpatients or outpatients, 18-65 years of age
- •Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
- •Evidence of unidimensional measurable disease as per RECIST criteria
- •No systemic metastatic disease (M0)
- •ECOG performance status of 0 or 1 at study entry
- •Effective contraception
- •White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
- •Total bilirubin ≤ 1.5x upper reference range
- •AST & ALT ≤ 1.5x upper reference range
- •Glomerular filtration rate > 60 ml/min
- •Serum creatinine ≤ 1.25x upper reference range
排除标准
- •Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
- •Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
- •Known hypersensitivity reaction to any of the components of study treatments
- •Pregnancy or lactation period
- •Systemic metastatic disease
- •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •Peripheral neuropathy > grade 1
- •Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
- •Known alcohol or drug abuse
- •Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
Cetuximab and chemotherapy
2 cycles of neoadjuvant cisplatin and 5FU (3 weekly), given with weekly cetuximab, followed by 7 doses of weekly cisplatin and cetuximab concurrent with radiotherapy
干预措施: Cetuximab (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 1 year
次要结局
- Objective response rate(1 year)
- Progression and overall survival(1 year)
研究者
Ho Gwo Fuang
Medical Lecturer
University of Malaya