Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer
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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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with colon cancer metastases to the liver
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| United States, Maryland | |
| Johns Hopkins Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| 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 June 13, 2013