Angiogenic Factor Expression During Fractionated Irradiation
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|ClinicalTrials.gov Identifier: NCT02072720|
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : March 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Esophageal Carcinoma||Drug: Bevacizumab||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
No Intervention: on-treatment tumor biopsie
patients will undergo an pre-treatment and on-treatment tumor biopsy, to measure VEGF expression, and identify the time point of induction of VEGF expression.
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.
patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression
Other Name: Bevacizumab (Avastin).
- Change of VEGF mRNA expression in tumor biopsies [ Time Frame: 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 [ Time Frame: 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.
- Changes of mRNA expression of other pro-angiogenic factors [ Time Frame: 5 weeks ]To identify the expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
- Changes in protein expression of pro-angiogenic factors [ Time Frame: 5 weeks ]To identify the protein expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
- Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis [ Time Frame: 5 weeks ]To identify the expression of CD31+ and pericyte markers with IHC staining in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072720
|Contact: Henk Verheul, MD/ PhDfirstname.lastname@example.org|
|VU university medical center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|Principal Investigator: Henk Verheul, MD/PhD|