Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 92
- 主要终点
- Objective response rate: complete response + partial response on RECIST evaluation system
研究概览
简要总结
Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of the study "Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN" was sponsored to evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN patients.
详细描述
condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form
- •Age 65-85，both genders
- •HNSCC Confirmed by pathology
- •Primary site of oral cavity, oropharynx, hypopharynx, larynx
- •Stage Ⅲ/ⅣA,B
- •Primary lesions can be measured
- •Karnofsky's Performance Scale ≥60
- •Life expectancy of more than 6 months
- •Haemoglobin≥100g/L ,WBC ≥3.5×109/L, platelet count≥90×109/L
- •Hepatic function: ALT、AST< 1.5 x ULN, TBIL< 1.5 x ULN
- •Renal function: Creatinine < 1.5 x ULN
排除标准
- •Received other anti EGFR monoclonal antibody treatment
- •Previous chemotherapy or radiotherapy
- •Participation in other interventional clinical trials within 1 month
- •Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
- •History of serious allergic or allergy
- •History of Serious lung or heart disease
研究组 & 干预措施
Radiotherapy + Nimotuzumab
- Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F
- Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT
干预措施: Nimotuzumab and Radiotherapy (Drug)
Radiotherapy (RT)
Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F
干预措施: Nimotuzumab and Radiotherapy (Drug)
结局指标
主要结局
Objective response rate: complete response + partial response on RECIST evaluation system
时间窗: 1-month after treatment
Evaluate the Safety of Nimotuzumab Combined with Radiotherapy for old patients. Record the Number and Grade of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: participants will be followed during the treatment,an expected average of 6 weeks
Objective response rate: complete response + partial response on RECIST
时间窗: 3-months after treatment
次要结局
- Evaluate the Local control Rate in 3 years.(up to 3 years)
- Evaluate the Local control Rate in 5 years.(up to 5 years)
- Evaluate the overall survival of the patient in 3 years.(up to 3 years)
- Evaluate the overall survival of the patient in 5 years.(up to 5 years)
- Evaluate the Local control Rate in 2 years.(up to 2 years)
- Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.(every 3 months after treatment)
- Evaluate the overall survival of the patient in 2 years.(up to 2 years)
- Evaluate the progression free survival of the patient in 2 years.(up to 2 years)
- Evaluate the progression free survival of the patient in 3 years.(up to 3 years)
- Evaluate the progression free survival of the patient in 5 years.(up to 5 years)