Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Disease Free Survival Time
研究概览
简要总结
The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.
详细描述
Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No prior treatment for esophageal cancer
- •No prior radiation to the chest or upper abdominal area
- •No prior treatment with an EGFR inhibitor or an anti-angiogenic agent
- •Disease should be limited to the esophagus and regional lymph nodes -
排除标准
- •History of stroke
- •History of heart attack
- •Inadequately controlled high blood pressure
研究组 & 干预措施
Bevacizumab
干预措施: Bevacizumab (Drug)
Bevacizumab
干预措施: Paclitaxel (Drug)
Bevacizumab
干预措施: Cisplatin (Drug)
Bevacizumab
干预措施: 5-Fluorouracil (Drug)
Bevacizumab
干预措施: Radiation Therapy (Radiation)
Bevacizumab
干预措施: Esophagectomy (Procedure)
结局指标
主要结局
Disease Free Survival Time
时间窗: 5 years
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
次要结局
- The Number of Patients Cancer Free at the Time of Surgery(1 year)
- The Proportion of Toxicities Experienced by Participants(Every three weeks for one year)
