Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers

NCT01445327 | Terminated Results

• 2 other identifiers: 07011107-C-0111
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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 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 National Cancer Institute (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 patients 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.

Conditions

Esophageal Cancer; Stomach Cancer; Pancreatic Cancer

Keywords

Blood; Urine; Stool; Tumor Marker; Radiation Therapy; Gastrointestinal Cancer; Esophageal Cancer; Stomach; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment

  Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease.

  Prior to treatment (baseline) and after treatment, up to 19 months

Secondary Outcomes (1)

• Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy

  After radiotherapy, up to 19 months

Other Outcomes (1)

• Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.

  Date treatment consent signed to date off study, an average of 19 months

Study Arms (1)

Markers of Tumor Burden and Radiation Toxicity

Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.

Other: Specimen collection

Interventions

Specimen collection OTHER

Markers of Tumor Burden and Radiation Toxicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with gastrointestinal tumors that will receive radiation therapy at the National Institutes of Health (NIH) Clinical Center as part of their treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.3322/canjclin.56.2.106.

  PMID: 16514137 BACKGROUND

• 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. doi: 10.1016/0090-4295(86)90146-9.

  PMID: 2431533 BACKGROUND

• 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. doi: 10.1097/00000421-198801102-00013.

  PMID: 2468274 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

10 cc in one ethylenediamine tetraacetic acid (EDTA) tube for plasma for Transforming growth factor beta 1 (TGFbeta1); 24cc total in serum separator tube (SST) for serum for extra-cellular markers; Stool - at least 10 gram (gm) in a sterile collection cup (leukocyte markers); Urine - at least 15 cubic centimeter (cc) in a sterile collection cup

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Dr. Deborah E. Citrin
• Organization: National Cancer Institute

citrind@mail.nih.gov

301-496-5457

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 3, 2011
• Study Start: February 20, 2007
• Primary Completion: May 22, 2014
• Study Completion: May 22, 2014
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)