NCT01291823Unknown2 期
A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
详细描述
Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer.
Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented diagnosis of esophageal Cancer
- •Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
- •age:70-85 years
- •Written informed consent.
- •Performance status of 0 to 2
- •Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.
- •Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
- •Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
排除标准
- •Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Prior systemic chemotherapy or radiation therapy for esophageal cancer
研究组 & 干预措施
Concomitant Gefitinib and radiotherapy
Experimental
Patients received Gefitinib and radiation therapy
干预措施: gefitinib (Drug)
Concomitant Gefitinib and radiotherapy
Experimental
Patients received Gefitinib and radiation therapy
干预措施: Thoracic radiotherapy (Radiation)
结局指标
主要结局
Tumor response rate
时间窗: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
次要结局
- The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)(1 month after treatment)
研究者
研究点 (1)
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