RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.

Condition	Treatment or Intervention	Phase
stage I rectal cancer stage I colon cancer prevention of colorectal cancer stage III colon cancer stage III rectal cancer stage II colon cancer stage II rectal cancer	Drug: aspirin  Drug: placebo	Phase III

Further Study Details: 

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.

PROTOCOL OUTLINE: Randomized, double-blind study.

Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223.

Arm II: Control. Placebo, PLCB.

PROJECTED ACCRUAL: Approximately 900 patients will be randomized over 4 years.

Ages Eligible for Study:  30 Years   -   74 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  10309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinical and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
Canada, Saskatchewan
      Saskatchewan Cancer Agency, Regina,  Saskatchewan,  S4S 6X3,  Canada

Study chairs or principal investigators

Robert S. Sandler,  Study Chair,  Cancer and Leukemia Group B   
Robert L. Comis,  Study Chair
Charles L. Loprinzi,  Study Chair

Study ID Numbers:  CDR0000078380; CLB-9270; NCI-P93-0048
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002527
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08