Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.
详细描述
OBJECTIVES:
Primary
- Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib hydrochloride in combination with radiotherapy.
Secondary
- Assess the proportion of patients achieving mucosal complete response after treatment with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Assess the effect of this regimen on dysphagia control, performance status, and overall quality of life of these patients.
- Investigate the correlation between smoking status and overall survival of these patients.
- To correlate the Epidermal growth factor receptor (EGFR) and phosphor Epidermal growth factor receptor (pEGFR) expression by IHC and EGFR mutation status with clinical outcomes.
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
- 65 Years 至 120 Years（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
Oral Erlotinib
Patients receive oral erlotinib hydrochloride once daily for 1 year
干预措施: radiation therapy (Radiation)
Oral Erlotinib
Patients receive oral erlotinib hydrochloride once daily for 1 year
干预措施: erlotinib hydrochloride (Drug)
Oral Erlotinib
Patients receive oral erlotinib hydrochloride once daily for 1 year
干预措施: immunohistochemistry staining method (Other)
结局指标
主要结局
Overall Survival
时间窗: 5 years
次要结局
- Complete Response(4-8 weeks after completion of radiation.)
- Progresssion-Free Survival(Every 3 months, up to 5 years)
- Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale(Baseline and Week 3)
- Correlation of Smoking Status With Overall Survival(5 years)
- Response by Epidermal Growth Factor Receptor (EGFR) Expression(Radiologic evaluation every 3 months, up to 5 years)
- Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression(Radiologic evaluation every 3 months, up to 5 years)
- Response by EGFR Mutation Status(Radiologic evaluation every 3 months, up to 5 years)