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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Study of Molecular Correlates of Response in Patients With Rectal Adenocarcinoma Undergoing Chemotherapy and Radiotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	UNC-LCCC-0216 LCCC 0216, NCT00280761

Trial Description

Purpose:

Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Planning to undergo chemotherapy and radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive fluorouracil or capecitabine and undergo radiation therapy. Some patients will also undergo surgery.

Patients will undergo tumor biopsies for laboratory studies at the beginning of the study and on days 1 and 2 of chemotherapy and radiation therapy. Some patients will also undergo transrectal ultrasound 6-8 weeks after finishing chemotherapy and radiation therapy.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Bert O'Neil, MD, Principal investigator		Ph: 919-843-7180

U.S.A.
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432

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Registry Information
Official Title		A Biologic Study of the Early Effects of Chemotherapy and Radiotherapy on Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum
Trial Start Date		2003-12-01
Trial Completion Date		2008-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00280761
Date Submitted to PDQ		2007-08-03
Information Last Verified		2008-07-27
NCI Grant/Contract Number		CA16086