A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- tumour local control rate
研究概览
简要总结
This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.
详细描述
Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.
Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •photographically and histologically proven thoracic esophageal squamous carcinoma
- •stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002)
- •radiochemotherapy indication
- •measurable tumor
- •adequate hematologic, hepatic and renal function
- •Karnofsky performance status ≥70
- •age more than 18years and less than 70 years
排除标准
- •pregnancy and lactation
- •significant neurologic disease
- •severe liver and renal malfunction,and Significant medical illness
- •previous chemotherapy, radiotherapy or immunotherapy
- •esophagus hemorrhage and esophagus perforation features
研究组 & 干预措施
2
Concurrent radiochemotherapy and placebo
干预措施: placebo (Drug)
1
concurrent radiochemotherapy and Sodium Glycididazole
干预措施: Sodium Glycididazole (Drug)
结局指标
主要结局
tumour local control rate
时间窗: 6 weeks
次要结局
- survival rate(one year)