Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

This study has been completed.
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00414492
First received: December 20, 2006
Last updated: September 15, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Choti, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00414492     History of Changes
Other Study ID Numbers: J06106, NA_00004883
Study First Received: December 20, 2006
Last Updated: September 15, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014