Angiogenic Factor Expression During Fractionated Irradiation

NCT ID: NCT02072720

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2021-05-01

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.

Conditions

Primary Esophageal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

Interventions

Bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

Bevacizumab (Avastin).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

H.M.W. Verheul

Prof. H.M.W. Verheul

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VU university medical center

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status: RECRUITING

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Henk Verheul, MD/ PhD

Role: CONTACT

h.verheul@vumc.nl

Facility Contacts

A. M. Van Berkel

Role: primary

H. W.M. van Laarhoven

Role: primary

Other Identifiers

2013/340

Identifier Type: -

Identifier Source: org_study_id