Status:
TERMINATED
Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Stomach Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Background: * Gastrointestinal cancers are among the most commonly diagnosed cancers in the United States. * There are currently no tests to predict how patients with gastrointestinal cancers will re...
Detailed Description
Background: * Gastrointestinal (GI) carcinomas represent one of the most commonly diagnosed malignancies in the United States. * A sensitive and specific marker of tumor persistence or recurrence wou...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years.
- Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, bile duct, rectum).
- Treatment plan includes radiotherapy to the site of the gastrointestinal malignancy on an National Cancer Institute (NCI) protocol.
- Paraffin embedded tumor tissue from biopsy or surgery adequate in amount to perform polymerase chain reaction (PCR) and methylation specific PCR or willingness to undergo re-biopsy.
- EXCLUSION CRITERIA:
- Inability to provide informed consent.
- Patients who have a history of prior therapeutic radiation.
- Patients with evidence of distant metastases on initial staging evaluation.
- Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.
- History of inflammatory bowel disease.
- History of collagen vascular disease or disease of altered collagen metabolism (end stage renal disease or hepatic fibrosis due to chronic hepatitis).
- History of hypersensitivity to radiation or a history of a disease which results in mucosal or other hypersensitivity to radiation (Ataxia-Telangiectasia, Bloom's Syndrome, Human Immunodeficiency Virus, Fanconi anemia, nevoid basal cell carcinoma syndrome, Li-Fraumeni syndrome, and Nijmegen breakage syndrome).
- Inability to return for follow-up visits.
- Patients who have previously received or are currently receiving MDX-101 (ipilimumab).
- Diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
Exclusion
Key Trial Info
Start Date :
February 20 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01445327
Start Date
February 20 2007
End Date
May 22 2014
Last Update
February 1 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892