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Chemoradiation and Endothelial Progenitor Cells in Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325871
First Posted: May 15, 2006
Last Update Posted: March 22, 2017
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 (Responsible Party):
Yu-Jen Chen, Mackay Memorial Hospital
  Purpose

Colorectal cancer (CRC) is one of the common malignancies worldwide, accounting for a significant percentage of cancer mortality. Concurrent chemoradiation (CCRT) is now a standard treatment for unresectable malignancies of anorectum. To improve quality of life, CCRT is also commonly applied in treatment of lower rectal and anal canal cancer to preserve anal sphincter function. The most commonly used chemotherapeutic drugs combined with radiation as radiosensitizers is 5-fluorouracil (5-FU). Circulating endothelial progenitor cells (EPC), which contribute to the tumor vessel formation, reflect the response to chemotherapy both in animal model and clinical trial. Thus, circulating EPC can be used as a marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis inhibitors and chemotherapy. Whether circulating EPC can be served as a marker of CCRT efficacy or not remains undetermined. Since CCRT is now a standard treatment of locally advanced and high-risk CRC, the development of a surrogate marker for monitoring CCRT response and optimize treatment intensity is very important.

In this grant we intent to monitor the levels of circulating EPC in locally advanced and high-risk CRC patients before, during and after CCRT. To further characterize the changes in function and biology of EPC caused by CCRT, a syngeneic animal model will be also used to evaluate the clonogenecity and specific gene expression of EPC in tumor-bearing mice receiving CCRT.


Condition Intervention
Colorectal Cancer Procedure: concurrent chemoradiation

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Concurrent Chemoradiation on Circulating Endothelial Progenitor Cells in Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Yu-Jen Chen, Mackay Memorial Hospital:

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rectal cancer post-op with CCRT
Criteria

Inclusion Criteria:

  • Colorectal cancer patients indicated for chemoradiation

Exclusion Criteria:

  • With major systemic disease including other cancer, diabetes, cardiovacular disease.
  • Received prior chemotherapy or radiotherapy within 1 month
  • Receiving immunosuppressants
  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): NCT00325871


Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Yu-Jen Chen, MD, PhD Department of Radiation Oncology, Mackay Memorial Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yu-Jen Chen, Head, Department of Radiation Oncology, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT00325871     History of Changes
Other Study ID Numbers: MMH-I-S-243
First Submitted: May 12, 2006
First Posted: May 15, 2006
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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