Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
研究概览
简要总结
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed prior to study entry
- •Age between 18-69 years old
- •Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
- •Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
- •Primary tumor measurable
- •KPS score ≥80
- •Expected life span ≥6 months
- •Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
- •Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN
- •Adequate renal function: Creatinine Clearance < 1.5×ULN
排除标准
- •Evidence of distant metastatic disease
- •Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
- •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 < 30ml/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 intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
研究组 & 干预措施
Cetuximab
400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
干预措施: C225 (cetuximab) (Drug)
结局指标
主要结局
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
时间窗: 3 months
The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.
次要结局
- 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival(5 year)