View Clinical Trial (Medical Research Study)
A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.
| City: |
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Chapel Hill |
| State: |
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North Carolina |
| Zip Code: |
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27599 |
| Conditions: |
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Colorectal Cancer |
| Purpose: |
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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 also help doctors understand how patients respond to treatment.
PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer
undergoing chemotherapy and radiation therapy.
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| Study Summary: |
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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 nature) with
therapeutic outcomes (as measured by rate of pathologic complete response or
downstaging by endoscopic ultrasound [EUS]).
Secondary
- Study downstream events induced by NF-kappa B activation.
- Determine global gene expression profiles at baseline and during chemoradiotherapy.
- Correlate changes in gene expression (compared with the baseline gene expression
pattern) induced by a single dose of external beam radiotherapy with patient outcomes
(as measured by pathologic response rate or downstaging by EUS).
- Study downstream events related to activation of p53 in response to treatment with
radiotherapy.
- Correlate p53 pathway-mediated events with clinical outcomes.
OUTLINE: Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery
per standard care.
Patients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy.
At the time of final surgical resection, a portion of the remaining rectal tumor will be
liquid nitrogen banked. Patients not deemed surgical candidates are evaluated by transrectal
ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response
(downstaging versus no downstaging).
Tumor tissue samples are analyzed for NF-kappa B pathway activation; downstream events
induced by NF-kappa B activation; changes in global gene expression; p53 function;
apoptosis; and mRNA expression. Laboratory techniques used include tissue microarray, ELISA,
RNase protection assay, fluorescence semi-quantitative PCR, TUNEL, IHC, and cDNA microarray
analysis.
If normal tissue from biopsies is not available, whole blood may be collected at any point
while patient remains on study for correlative analysis or research related to rectal
cancer.
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| Criteria: |
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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
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| NCT ID: |
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NCT00280761 |
| Primary Contact: |
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Principal Investigator
Bert H. O'Neil, MD
UNC Lineberger Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chapel Hill, North Carolina 27599
United States
Bert O'Neil, MD
Phone: 919-966-4432
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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