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Phase 3
30 Years
74 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information


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.

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

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Principal Investigator

Robert S. Sandler, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 1993

Completion Date:

January 2006

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms



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