Search / Trial NCT00002527

Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Aug 30, 2004

Trial Information

Current as of December 26, 2024

Completed

Keywords

Colon Cancer Rectal Cancer

ClinConnect Summary

OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.

OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically documented colorectal cancer that has been curatively resected, including: Dukes' A/B1 (T1-2, N0, M0) Dukes' B2/C (T3, N0, M0 and any T, N1, M0) disease-free more than 5 years post-resection Colonoscopy to the cecum (or small bowel anastomosis) with removal of all polyps required within 4 months of entry Preparation must be adequate to visualize mucosa and discern the presence of no further polyps No familial polyposis (more than 100 polyps at time of resection) No history of inflammatory bowel disease including ulcerative colitis or Crohn's disease
  • PATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women
  • PRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required

Trial Officials

Robert Sandler, MD, MPH

Study Chair

UNC Lineberger Comprehensive Cancer Center

About Alliance For Clinical Trials In Oncology

The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.

Locations

Buffalo, New York, United States

Rochester, Minnesota, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Providence, Rhode Island, United States

Burlington, Vermont, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

San Francisco, California, United States

Miami Beach, Florida, United States

Baltimore, Maryland, United States

Columbia, Missouri, United States

Saint Louis, Missouri, United States

Lebanon, New Hampshire, United States

Manhasset, New York, United States

Syracuse, New York, United States

Winston Salem, North Carolina, United States

Memphis, Tennessee, United States

Richmond, Virginia, United States

Peoria, Illinois, United States

Urbana, Illinois, United States

Des Moines, Iowa, United States

Scottsdale, Arizona, United States

Cedar Rapids, Iowa, United States

Sioux City, Iowa, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Saint Cloud, Minnesota, United States

New York, New York, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Grand Forks, North Dakota, United States

Toledo, Ohio, United States

Danville, Pennsylvania, United States

Rapid City, South Dakota, United States

Sioux Falls, South Dakota, United States

Regina, Saskatchewan, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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