A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Late xerostomia rate
研究概览
简要总结
Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.
详细描述
Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.
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
- •newly diagnosed squamous cell head and neck cancer
- •inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy
- •Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine < 130 / mmol.L-1, Transaminase ≤ 3 x upper limit
排除标准
- •Distant metastases
- •Prophylactic use of pilocarpine
- •Concomitant chemotherapy
结局指标
主要结局
Late xerostomia rate
次要结局
未报告次要终点