A Pilot Study of Markers of Tumor Burden and Radiation Toxicity in the Blood, Urine, and Stool of Patients Receiving Radiotherapy for Gastrointestinal Malignancies
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Colorectal Cancer - Esophageal Cancer - Extrahepatic Bile Duct Cancer - Gallbladder Cancer - Gastric Cancer - Gastrointestinal Complications - Liver Cancer - Pancreatic Cancer - Radiation Toxicity |
| Purpose: |
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RATIONALE: Studying samples of blood, urine, stool, and 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 predict the side effects of
radiation therapy and plan the best treatment.
PURPOSE: This clinical trial is studying biomarkers and radiation side effects in patients
undergoing radiation therapy for gastrointestinal cancer .
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine if tumor-specific DNA mutations and aberrant DNA methylation can be detected
in the serum, urine, or stool at the time of diagnosis in patients undergoing
radiotherapy for gastrointestinal malignancies.
- Determine if changes in mutational status at follow up are associated with disease
persistence, recurrence, or survival of these patients.
- Determine if pre-treatment, post-treatment, and follow up measurements of TGFβ1 in the
urine and plasma can be used to predict late gastrointestinal toxicity in these
patients.
Secondary
- Determine which biological fluid (serum, urine, or stool) is most highly associated
with the detection of tumor-specific DNA mutations and tumor-specific DNA methylation
and provides the best source of tumor-specific DNA to measure at follow up for
association with disease persistence, recurrence, or survival.
- Determine if novel serum, urine, and stool biomarkers obtained at the time of treatment
and shortly after treatment can be used to predict the likelihood of chronic
gastrointestinal toxicity in these patients.
- Determine if novel serum, urine, and stool biomarkers obtained at the time of treatment
and shortly after treatment are influenced by the radiation dose delivered to abdominal
organs in these patients.
OUTLINE: This is a pilot, prospective, longitudinal study.
Serum, plasma, urine, and stool samples are collected prior to any treatment, prior to
radiotherapy, at completion of radiotherapy, and at 1, 3, 6, 12, 24, and 36 months after
completion of radiotherapy for research studies. Tumor tissue collected at biopsy or
resection and biological samples are analyzed by polymerase chain reaction (PCR) and
methylation-specific PCR.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the gastrointestinal (GI) tract, including any
of the following sites:
- Esophagus
- Stomach
- Pancreas
- Bile duct
- Rectum
- Planning to receive radiotherapy to site of GI malignancy on a National Cancer
Institute clinical trial
- No evidence of distant metastases
- Adequate paraffin-embedded tumor tissue available OR willing to undergo biopsy
PATIENT CHARACTERISTICS:
- No history of inflammatory bowel disease
- No history of collagen vascular disease or disease of altered collagen metabolism
(i.e., end-stage renal disease or hepatic fibrosis due to chronic hepatitis)
- No history of hypersensitivity to radiotherapy
- No history of a disease that results in mucosal or other hypersensitivity to
radiotherapy, including any of the following:
- Ataxia-telangiectasia
- Bloom's syndrome
- Fanconi's anemia
- Nevoid basal cell carcinoma syndrome
- Li-Fraumeni syndrome
- Nijmegen breakage syndrome
- No HIV infection or hepatitis B or C
- No other concurrent cancer, except nonmelanoma skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior complete resection of GI malignancy
- No prior therapeutic radiotherapy
- No prior or concurrent ipilimumab
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| NCT ID: |
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NCT00452946 |
| Primary Contact: |
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Principal Investigator
Deborah E. Citrin, MD
NCI - Radiation Oncology Branch; ROB
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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