Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change of VEGF mRNA expression in tumor biopsies
研究概览
简要总结
The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.
- Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).
- If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma
- •ability to give informed consent
- •age 18 years or older
排除标准
- •pregnancy
- •evidence of bleeding diathesis, coagulopathy
- •inflammation of the GI-tract
- •brain metastases
- •diastolic/ systolic hypertension, not responding to treatment
- •arterial thromboembolism in medical history
- •surgery within the month prior to start of bevacizumab treatment
研究组 & 干预措施
bevacizumab
These patients will receive bevacizumab once a week during their chemoradiation, starting at the identified time point of enhanced VEGF expression. These patients will also undergo and pre-treatment tumor biopsy and 1 tumor biopsy 1 week after the start of bevacizumab treatment.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Change of VEGF mRNA expression in tumor biopsies
时间窗: 5 weeks
To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline.
Change of VEGFR2 phosphorylation with IHC
时间窗: 8 weeks
To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline.
次要结局
- Changes of mRNA expression of other pro-angiogenic factors(5 weeks)
- Changes in protein expression of pro-angiogenic factors(5 weeks)
- Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis(5 weeks)
研究者
H.M.W. Verheul
Prof. H.M.W. Verheul
Amsterdam UMC, location VUmc