Angiogenic Factor Expression During Fractionated Irradiation

Amsterdam UMC, location VUmc

Status and phase: Unknown; Early Phase 1

Conditions: Primary Esophageal Carcinoma

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02072720

2013/340

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

on-treatment tumor biopsie

No Intervention group

Description:

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.

bevacizumab

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab