Angiogenic Factor Expression During Fractionated Irradiation

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT02072720
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Primary Esophageal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 26, 2014
Start date
Feb 28, 2014
Status verified
Oct 2019
Primary completion
Mar 31, 2021
Completion
May 1, 2021

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: bevacizumab
    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.

Primary Outcome Measure

Change of VEGF mRNA expression in tumor biopsies [ Time Frame: 5 weeks ]

Central Contacts