A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, with or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.
Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.
详细描述
This is a phase III, superiority, national, open-label, randomized, and two-arm study.
Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.
All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiation therapy, cisplatin and nimotuzumab
Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months.
Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week
Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)
干预措施: Nimotuzumab (Drug)
Radiation therapy and cisplatin
Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week
Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)
干预措施: Radiation Therapy (Radiation)
Radiation therapy and cisplatin
Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week
Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 6 months
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
次要结局
- Complete clinical response rate(2 years)