Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Pathological Complete Response
研究概览
简要总结
EGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.
详细描述
The primary endpoint of this study is the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1, 3, 5 years), overall survival rate (3, 5 years), and the safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to any study activities
- •Age 18-75
- •Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
- •Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
- •Karnofsky performance status (KPS) ≥70
- •Adequate hematologic function: Neutrophils ≥1,500/mm^3, WBC >4,000/mm^3, Hb > 10 g/dL, platelet count >100,000/mm^3
- •Hepatic function: ALAT/ASAT <2.5 times the upper limit of normal (ULN), bilirubin <1.5 x ULN
- •Renal function: serum creatinine <1.5 x ULN
- •Life expectancy ≥6 months
排除标准
- •Evidence of distant metastatic disease and other oropharyngeal cancers
- •Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
- •Previous radiotherapy for the primary tumor or lymph nodes
- •Previous exposure to epidermal growth factor-targeted therapy
- •Prior chemotherapy or immunotherapy for the primary tumor
- •Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
- •Any investigational agent prior to the 1st study medication
- •Participation in another clinical study within the 30 days prior to Inclusion in this study.
- •Peripheral neuropathy >grade 1
- •Known grade 3 or 4 allergic reaction to any of the study treatment
- •History of severe pulmonary or cardiac disease
- •Creatinine Clearance <30 ml/min
- •Know drug abuse /alcohol abuse
- •Legal incapacity or limited legal capacity
- •Active systemic infection
- •Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
- •Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
- •Pregnancy (confirmed by serum or urine β-HCG) or lactation period
- •Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months
研究组 & 干预措施
Neo-adjuvant Erbitux-based chemotherapy
Neo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, Docetaxel, Cisplatin.
干预措施: Neo-adjuvant Erbitux-based chemotherapy (Drug)
结局指标
主要结局
Pathological Complete Response
时间窗: Up to 6 months
To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.
次要结局
- Disease Free Survival(5 years)
- Locoregional Control rates(5 years)
- Overall Survival(5 years)
- Number of Participants with Adverse Events(5 years)
研究者
Lai-ping Zhong
Ninth People's Hospital, School of Medicine
Shanghai Jiao Tong University School of Medicine