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Investigator(s):
Deborah Citrin, M.D. Principal Investigator Phone: 301-496-5457 citrind@mail.nih.gov
Referral Contact(s):
Sharon L. Smith, R.N., M.S., O.C.N., C.C.R.P. Research Nurse Phone: 301-496-5457 Fax: 301-480-2347 smiths@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed carcinoma of the gastrointestinal (GI) tract including:
• Esophagus
• Stomach
• Pancreas
• Bile duct
• Rectum
• Planning to receive radiotherapy to site of GI malignancy on an NCI clinical trial
• No evidence of distant metastasis
• Adequate paraffin-embedded tumor tissue available or willing to undergo biopsy
• No prior resection of GI malignancy
• No prior therapeutic radiotherapy
• No prior or concurrent ipilimumab
• 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 radiation
• No history of disease that results in mucosal or other hypersensitivity to radiation, 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 non-melanoma skin cancer or carcinoma in situ

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Study 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 treatment for research studies
• Tumor tissue collected at biopsy or resection and biological samples are analyzed by polymerase chain reaction (PCR) and methylation-specific PCR
• Patients also undergo intestinal permeability tests prior to therapy and at 1 and 3 months after completion of radiotherapy

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/10/09
Updated: 5/14/09