Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Overall Survival
研究概览
简要总结
Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.
详细描述
Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cytologically or histologically verified anaplastic thyroid cancer
- •completed standard therapy
- •operated with R0 or R1 surgery
- •Performance Status 0-2 (if pulmonary mets PS 0-1)
- •normal wound healing
- •neutrophils > 1,5 million/ml
- •platelets > 100 million/ml
- •bilirubin < 2 ULN
- •creatinin < 150mikromol/L
排除标准
- •PS 3-4 (if pulmonary mets 2-4)
- •R2 resection of primary tumor
研究组 & 干预措施
chemotherapy
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: 2-5 years
次要结局
- Response rate(2-5 years)