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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016086 | U.S. NIH Grant/Contract | View source | |
| CDR0000561688 | Other Identifier | PDQ number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Single Arm Trial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of NF-kappa B in response to treatment with external beam radiotherapy | 6-8 weeks after chemoradiation | |
| Correlation of NF-kappa B pathway activation with therapeutic outcomes | 6-8 weeks after chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Downstream events induced by NF-kappa B activation | 12 months | |
| Global gene expression profiles at baseline and during chemoradiotherapy | prior to chemoradiation and 72 days post chemoradiation | |
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DISEASE CHARACTERISTICS:
Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample
Candidate for chemotherapy and radiotherapy, as defined by any of the following:
Planning to undergo chemotherapy and radiotherapy
No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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All patients (male, female, any ethnic background) with rectal (inferior margin of the tumor less than 15cms from anal verge by rigid sigmoidoscopy or below the level of S1-2 at operation) or sigmoid-rectal junction carcinomas confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample.
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Sanoff, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
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| Label | URL |
|---|---|
| web address for UNC Lineberger Comprehensive Cancer Center | View source |
| web address for the National Cancer Institute (NCI) | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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Adenocarcinoma of the Rectum
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| 5-fluorouracil | Drug | Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist. |
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| Surgical Resection | Procedure | Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease). |
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| Radiation therapy | Radiation | Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist. |
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| Correlation of changes in gene expression with patient outcomes |
| 72 days post chemoradiation |
| Downstream events related to activation of p53 in response to treatment with radiotherapy | 72 post radiotherapy |
| Correlation of p53 pathway-mediated events with clinical outcomes | 72 days post chemoradiation |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |