Primary Esophageal Carcinoma Clinical Trial
Official title:
Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
| Verified date | October 2019 |
| Source | VU University Medical Center |
| Contact | Henk Verheul, MD/ PhD |
| h.verheul[@]vumc.nl | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | May 1, 2021 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma - ability to give informed consent - age 18 years or older Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Noordwest Ziekenhuisgroep | Alkmaar | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | VU university medical center | Amsterdam | Noord-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| VU University Medical Center | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Noordwest Ziekenhuisgroep |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of VEGF mRNA expression in tumor biopsies | To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline. | 5 weeks | |
| Primary | Change of VEGFR2 phosphorylation with IHC | 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. | 8 weeks | |
| Secondary | Changes of mRNA expression of other pro-angiogenic factors | 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). | 5 weeks | |
| Secondary | Changes in protein expression of pro-angiogenic factors | 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). | 5 weeks | |
| Secondary | Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis | 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). | 5 weeks |