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

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ClinicalTrials.gov Identifier: NCT00002527
Recruitment Status : Completed
First Posted : August 31, 2004
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: aspirin Other: placebo Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study
Study Start Date : May 1993
Primary Completion Date : March 2003
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aspirin
325 mg/day PO
Drug: aspirin
Placebo Comparator: Placebo Other: placebo



Primary Outcome Measures :
  1. Reduction in size of tumors [ Time Frame: Up to 4 years ]
  2. Reduction in number of tumors [ Time Frame: Up to 4 years ]
  3. Disease free survival [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002527


  Show 42 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Robert Sandler, MD, MPH UNC Lineberger Comprehensive Cancer Center

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002527     History of Changes
Other Study ID Numbers: CALGB-9270
CLB-9270
E-C9270
NCCTG-949251
NCI-P93-0048
CDR0000078380 ( Registry Identifier: NCI Physician Data Query )
First Posted: August 31, 2004    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Aspirin
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics