Angiogenic Factor Expression During Fractionated Irradiation

Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02072720

Enrollment

Registered

2014-02-26

Start date

2014-02-28

Completion date

2021-05-01

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Esophageal Carcinoma

Keywords

Radiotherapy, VEGF, esophagus carcinoma, bevacizumab

Brief summary

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.

Interventions

DRUGBevacizumab

patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of VEGF mRNA expression in tumor biopsies	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	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.

Secondary

Measure	Time frame	Description
Changes of mRNA expression of other pro-angiogenic factors	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	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	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).

Countries

Netherlands

Contacts

Primary ContactHenk Verheul, MD/ PhD

h.verheul@vumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026