Angiogenic Factor Expression During Fractionated Irradiation
Conditions
Primary Esophageal Carcinoma
Conditions: official terms
Carcinoma - Esophageal Neoplasms
Conditions: Keywords
Radiotherapy, VEGF, esophagus carcinoma, bevacizumab
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bevacizumab
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
VU university medical center
Amsterdam, Noord-Holland, Netherlands
Status: Recruiting
Start Date
February 2014
Completion Date
April 2016
Sponsors
VU University Medical Center
Source
VU University Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page