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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study|
|Study Start Date :||May 1993|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||January 2006|
325 mg/day PO
|Placebo Comparator: Placebo||
- Reduction in size of tumors [ Time Frame: Up to 4 years ]
- Reduction in number of tumors [ Time Frame: Up to 4 years ]
- Disease free survival [ Time Frame: Up to 4 years ]
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
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|Study Chair:||Robert Sandler, MD, MPH||UNC Lineberger Comprehensive Cancer Center|