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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



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
CentraCare Clinic Saint Cloud, Minnesota  56303
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080