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

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ClinicalTrials.gov Identifier: NCT01591109
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease
Colorectal Cancer

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Retrospective
Official Title: 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.
Study Start Date : January 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Biospecimen Retention:   Samples Without DNA
formalin fixed oarafin embedded block of liver specimen

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents cared by the institution this study was perfomed.
Criteria

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:

More Information

Responsible Party: Hiroshi Kitamura, Chief of Surgical Department, NHO - Matsumoto Medical Center
ClinicalTrials.gov Identifier: NCT01591109     History of Changes
Other Study ID Numbers: 24-1
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents