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
  Purpose

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
Colorectal Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by NHO - Matsumoto Medical Center:

Biospecimen Retention:   Samples Without DNA

formalin fixed oarafin embedded block of liver specimen


Enrollment: 20
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 2, 2012
Last Updated: May 2, 2012
Health Authority: Japan: Institutional Review Board
United States: Federal Government

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014