A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroshi Kitamura, NHO - Matsumoto Medical Center
ClinicalTrials.gov Identifier:
NCT01591109
First received: May 2, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 2, 2012
May 2, 2012
January 2010
April 2012   (final data collection date for primary outcome measure)
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No Changes Posted
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A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy
A Reversal in the Vascularity of Metastatic Liver Tumors in Patients With Colorectal Cancer After the Cessation of Anti-VEGF Therapy: A Study Using Contrast-enhanced Ultrasonography and Histological Techniques.

Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer.

Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking.

Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.

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Observational
Time Perspective: Retrospective
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Retention:   Samples Without DNA
Description:

formalin fixed oarafin embedded block of liver specimen

Non-Probability Sample

Residents cared by the institution this study was perfomed.

Colorectal Cancer
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  • Bevacizumab including chemotherapy
    Patients treated with bevacizumab including chemotherapy for metastatic liver tumor derived from colorectal cancer before metastasectomy.
  • no adjuvant chemotherapy
    Patients with no adjuvant chemotherapy including bevacizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes.

Exclusion Criteria:

  • none
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01591109
24-1
Yes
Hiroshi Kitamura, NHO - Matsumoto Medical Center
NHO - Matsumoto Medical Center
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NHO - Matsumoto Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP