Protocol Number: 07-C-0111

Title:

A Pilot Study of Markers of Tumor Burden and Radiation Toxicity in the Blood, Urine, and Stool of Patients Receiving Radiotherapy for Gastrointestinal Malignancies

Number:

07-C-0111

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 respond to radiation therapy or which patients may develop side effects from treatment.

-Studies on tumor cells in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients may need more or less aggressive therapy.

-Studies of other substances in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients are likely to develop side effects from radiation treatments.

Objectives:

-To collect blood, urine and stool specimens from patients with gastrointestinal cancers who will undergo radiation therapy.

-To study hormone and protein changes in these blood, urine and stool specimens before, during and after radiation treatment in order to develop a way to predict how gastrointestinal cancers will respond to radiation therapy and if patients with these cancers will develop side effects from radiation treatment.

Eligibility:

-Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an NCI protocol

Design:

Participants undergo the following procedures:

-Tumor biopsy: Before any treatment or at the time of surgery if it is the first treatment

-Urine collection: Before, during, and after treatment and at follow-up visits.

-Stool collection: Before, during, and after treatment and at follow-up visits.

-Blood collection: Before, during, and after treatment and at follow-up visits.

-Intestinal permeability assessment: Before any treatment, before radiation (if radiation is not the first treatment), 1 month after radiation is completed, and 3 months after radiation is completed. This test determines how the patient's intestines are working to absorb sugar and may provide information about side effects from radiation treatments. Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour urine collection.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

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 NCI protocol.

-Paraffin embedded tumor tissue from biopsy adequate in amount to perform PCR and methylation specific PCR or willingness to undergo rebiopsy.

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.

-Patients who have undergone complete resection of the gastrointestinal malignancy prior to protocol enrollment.

-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-Telengiectasia, 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 HIV, Hepatits B, or Hepatits C.

Special Instructions:

Currently Not Provided

Keywords:

Blood

Urine

Stool

Tumor Marker

Radiation Therapy

Recruitment Keyword(s):

Gastrointestinal Cancer

Esophageal Cancer

Stomach

Pancreatic Cancer

Condition(s):

Esophageal Cancer

Stomach Cancer

Pancreatic Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.

Seamonds B, Yang N, Anderson K, Whitaker B, Shaw LM, Bollinger JR. Evaluation of prostate-specific antigen and prostatic acid phosphatase as prostate cancer markers. Urology. 1986 Dec;28(6):472-9.

Guillet J, Role C, Duc AT, Francois H. Prostate-specific antigen (PSA) in the management of 500 prostatic patients. Am J Clin Oncol. 1988;11 Suppl 2:S61-2.

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