Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers
|ClinicalTrials.gov Identifier: NCT01445327|
Recruitment Status : Terminated
First Posted : October 3, 2011
Last Update Posted : October 6, 2017
- 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.
- 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.
-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
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.
|Condition or disease|
|Esophageal Cancer Stomach Cancer Pancreatic Cancer|
- 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 would permit a more accurate determination of the appropriateness of adjuvant therapy in patients with no clinical evidence of disease following curative resection and allow the diagnosis of recurrences at earlier stages that may be amenable to curative salvage therapies.
- A biomarker detectable shortly after treatment or in the early stages of chronic radiation toxicity may allow the identification of patients at risk and early intervention.
- Our primary objective is to determine if patient specific tumor markers in stool, urine, or serum can be reliably detected prior to treatment and followed after treatment to monitor the extent of residual disease.
- A second objective is to evaluate the predictive value of potential markers of chronic gastrointestinal injury after radiotherapy.
- Age greater than or equal to 18 years
- Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, rectum)
- Planned to receive radiotherapy to the site of the gastrointestinal malignancy on an NCI protocol
- This protocol provides a means of acquiring tissue, serum, urine, and stool samples from patients who will receive radiation therapy as part of their treatment for gastrointestinal malignancies.
- Patients treated with radiation therapy on NCI treatment protocols will be asked to provide samples prior to any local or systemic therapy as well as before, during and after their radiation treatment.
- These samples will be tested for the presence of tumor specific DNA mutations and aberrant methylation patterns determined to be present in each patient s tumor by screening of initial biopsy or surgical material.
- Tumor markers specific to each patient, such as tumor specific DNA mutations or aberrant DNA methylation, may provide an individualized method to evaluate disease status and determine prognosis after therapy. Additionally, a number of stool and serum markers will be explored as early indicators of acute and eventual chronic gastrointestinal injury in patients receiving radiotherapy to the abdomen.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official 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|
|Study Start Date :||February 20, 2007|
|Study Completion Date :||January 20, 2015|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445327
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|