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High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed Clinical research trials and High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed. High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed clinical trial. Participants oftentimes recieve the finest healthcare available for their High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed  High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
For Condition: Rectal Cancer,prevention of colorectal cancer,Colon Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of folic acid may be an effective way to prevent colorectal cancer in patients with polyps that have been surgically removed. PURPOSE: Randomized phase II trial to study the effectiveness of high-dose folic acid in preventing colorectal cancer in patients who have had polyps surgically removed within 18 months of the trial.
Details: OBJECTIVES: I. Determine whether high-dose folic acid decreases global DNA hypomethylation, as well as other intermediary markers, in normal-appearing colonic epithelium of patients with colonic adenomas. II. Determine whether a decrease in global DNA hypomethylation and other intermediary markers can be induced safely and whether these effects persist after folic acid is discontinued in these patients. III. Confirm pilot data that indicates patients with adenomas have widespread DNA hypomethylation of the colorectal mucosa compared to controls. IV. Evaluate the effect of folic acid on the clinical course and rate of recurrence of adenomatous polyps in these patients. V. Study a control group of patients with no history of neoplastic, hyperplastic, or inflammatory colorectal lesions. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and age (50-70 vs 30-49 and over 70). Patients with adenomatous polyps at least 10 mm at colonoscopy are randomized to 1 of 2 treatment arms. Patients found to have no neoplastic, hyperplastic, or inflammatory polyps at colonoscopy are assigned to a control (untreated) group and complete laboratory studies and a baseline food frequency questionnaire only. Arm I: Patients receive folic acid daily. Arm II: Patients receive placebo daily. Treatment continues in both arms for 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed at 1 year. PROJECTED ACCRUAL: A total of 80 patients (30 per arm and 20 for the control group) will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 21 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Colonic adenoma(s) of at least 10 mm completely resected within 18 months prior to randomization or suspected adenomatous polyp(s) - Colonoscopy with submission of at least 7 rectosigmoid biopsies required at entry; No benign hyperplastic polyps or polyps less than 10 mm to be eligible for treatment; No polyposis coli (i.e., more than 100 polyps in colon) - No history of invasive colorectal cancer --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No concurrent methotrexate - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics; No prior small bowel resection - Other: No concurrent anticonvulsants; No concurrent drugs that markedly interfere with folate absorption or metabolism (e.g., sulfasalazine and phenytoin); No concurrent vitamins during and for 2 years after beginning of study --Patient Characteristics-- - Age: 21 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count greater than 100,000/mm3; Hemoglobin greater than 10 g/dL; No untreated pernicious anemia - Hepatic: Bilirubin less than 2 mg/dL; ALT less than 2 times normal; Alkaline phosphatase less than 2 times normal; PT normal - Renal: Not specified - Gastrointestinal: No intestinal malabsorption; No inflammatory bowel disease - Other: No seizure within the past year; No poor medical risk; No other malignancy within past 5 years except basal cell cancer, superficial skin cancer, or carcinoma in situ of the cervix; No vitamin B12 deficiency (less than 200 pg/mL); Not pregnant or nursing; Fertile patients must use effective barrier contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelMason, Study Chair, Eastern Cooperative Oncology Group
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
USDA Human Nutrition Research Center
Boston, Massachusetts, 02111
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Additional Information:
Study ID Numbers: CDR0000064180; E-8292,NCI-P95-0066
Study Start Date: April 1995
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002650
Other Prevention Of Colorectal Cancer Studies:
1. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
2. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
3. Interleukin-12 in Treating Patients With Cancer in the Abdomen
4. Floxuridine, Dexamethasone, and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer
5. DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Related Studies:
Other prevention of colorectal cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
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