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Angiogenic Factor Expression During Fractionated Irradiation

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ClinicalTrials.gov Identifier: NCT02072720
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Primary Esophageal Carcinoma Drug: Bevacizumab Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
Study Start Date : February 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Bevacizumab
patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression
Other Name: Bevacizumab (Avastin).



Primary Outcome Measures :
  1. Change of VEGF mRNA expression in tumor biopsies [ Time Frame: 5 weeks ]
    To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline.

  2. Change of VEGFR2 phosphorylation with IHC [ Time Frame: 8 weeks ]
    To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline.


Secondary Outcome Measures :
  1. Changes of mRNA expression of other pro-angiogenic factors [ Time Frame: 5 weeks ]
    To identify the expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).

  2. Changes in protein expression of pro-angiogenic factors [ Time Frame: 5 weeks ]
    To identify the protein expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).

  3. Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis [ Time Frame: 5 weeks ]
    To identify the expression of CD31+ and pericyte markers with IHC staining in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072720


Contacts
Contact: Henk Verheul, MD/ PhD h.verheul@vumc.nl

Locations
Netherlands
VU university medical center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Principal Investigator: Henk Verheul, MD/PhD         
Sponsors and Collaborators
VU University Medical Center

Responsible Party: H.M.W. Verheul, Prof. H.M.W. Verheul, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02072720     History of Changes
Other Study ID Numbers: 2013/340
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by H.M.W. Verheul, VU University Medical Center:
Radiotherapy
VEGF
esophagus carcinoma
bevacizumab

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Bevacizumab
Angiogenesis Inducing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents