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Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414492
First Posted: December 21, 2006
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
  Purpose
Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite "negative" resection boundaries in these cases.

Condition
Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Biospecimen Retention:   Samples With DNA
liver tissue from surgical specimen

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: June 2010
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colon cancer metastases to the liver
Criteria

Inclusion Criteria:

  • Patients must be ≥ 18 years old.
  • Patients must have colon cancer metastases to the liver.
  • Patients must be candidates and be scheduled for liver resection.
  • Patients must have received and have had a response to neoadjuvant therapy prior to liver resection.
  • Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study.

Exclusion Criteria:

  • Patients who are < 18 years old.
  • Patients who do not have colon cancer metastases to the liver.
  • Patients who are not surgical candidates.
  • Patients who do not schedule or who cancel a liver resection.
  • Patients who have not received neoadjuvant therapy.
  • Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression.
  Contacts and Locations
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): NCT00414492


Locations
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Michael A Choti, MD Johns Hopkins University
  More Information

Responsible Party: Michael Choti, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00414492     History of Changes
Other Study ID Numbers: J06106
NA_00004883
First Submitted: December 20, 2006
First Posted: December 21, 2006
Last Update Posted: September 16, 2010
Last Verified: September 2010

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
metastatic colorectal cancer
liver metastasis
tumor margins
neoadjuvant therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases