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Trial Title:
Angiogenic Factor Expression During Fractionated Irradiation
NCT ID:
NCT02072720
Condition:
Primary Esophageal Carcinoma
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Bevacizumab
Conditions: Keywords:
Radiotherapy
VEGF
esophagus carcinoma
bevacizumab
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time
point of VEGF expression
Arm group label:
bevacizumab
Other name:
Bevacizumab (Avastin).
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
VU university medical center
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Investigator:
Last name:
Henk Verheul, MD/PhD
Email:
Principal Investigator
Facility:
Name:
Noordwest Ziekenhuisgroep
Address:
City:
Alkmaar
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A. M. Van Berkel
Facility:
Name:
Academisch Medisch Centrum
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
H. W.M. van Laarhoven
Start date:
February 2014
Completion date:
May 1, 2021
Lead sponsor:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
Noordwest Ziekenhuisgroep
Agency class:
Other
Collaborator:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Source:
Amsterdam UMC, location VUmc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02072720
