Status:
COMPLETED
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: 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 al...
Detailed Description
OBJECTIVES: Primary * Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy. * Correlate NF-kappa B pathway activation (presumed to be anti-apoptotic in na...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample
- Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery
- Candidate for chemotherapy and radiotherapy, as defined by any of the following:
- Tumor staged as T3 or N1-2 by rectal sonography
- Tumor occupying \> 40% of circumference of rectum
- Tumor fixed to extra colonic structures as determined by digital rectal examination
- Tumor \< 5 cm from sphincter mechanism
- Patient has inoperable disease and is being treated for palliation
- Pelvic or anastomotic recurrences of previously resected rectal cancer
- Planning to undergo chemotherapy and radiotherapy
- No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)
- PATIENT CHARACTERISTICS:
- Not pregnant
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 19 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00280761
Start Date
December 1 2003
End Date
September 19 2021
Last Update
August 11 2022
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295