Bethesda, Maryland 20892

  • Radiation Toxicity

Purpose:

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 .


Study summary:

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.


Criteria:

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


NCT ID:

NCT00452946


Primary Contact:

Principal Investigator
Deborah E. Citrin, MD
NCI - Radiation Oncology Branch; ROB


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 07, 2022

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