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
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Aspirin
Donnée non disponible
325 mg/day PO
Inconnu
Placebo
Donnée non disponible
Donnée non disponible
Inconnu
Aspirin
État du recrutement
unknown
325 mg/day PO
Placebo
État du recrutement
unknown
Données à jour depuis :
30 juin 2016
Description de l'étude
Description de l'étude
Résumé de l'étude
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.
Source : Importé depuis le centre
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.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
42
centres
ALTRU HEALTH SYSTEMS
Grand forks
NORTH DAKOTA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
BARNES-JEWISH HOSPITAL
Saint louis
MISSOURI, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - ANN ARBOR REGIONAL
Ann arbor
MICHIGAN, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - CARLE CANCER CENTER
Urbana
ILLINOIS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - CEDAR RAPIDS ONCOLOGY PROJECT
Cedar rapids
IOWA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - GEISINGER CLINICAL AND MEDICAL CENTER
Danville
PENNSYLVANIA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - ILLINOIS ONCOLOGY RESEARCH ASSOCIATION
Peoria
ILLINOIS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - IOWA ONCOLOGY RESEARCH ASSOCIATION
Des moines
IOWA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - MERIT CARE HOSPITAL
Fargo
NORTH DAKOTA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
CCOP - MISSOURI VALLEY CANCER CONSORTIUM
Omaha
NEBRASKA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
30 juin 2016
Données à jour depuis :
26 juin
Origine des données :
clinicaltrials.gov