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Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

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ClinicalTrials.gov Identifier: NCT00414492
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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 or disease
Metastatic Colorectal Cancer

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer
Study Start Date : December 2006
Actual Study Completion Date : June 2010



Biospecimen Retention:   Samples With DNA
liver tissue from surgical specimen


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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.

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 at Johns Hopkins
Investigators
Principal Investigator: Michael A Choti, MD Johns Hopkins University

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

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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