Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00983580 |
Recruitment Status :
Completed
First Posted : September 24, 2009
Results First Posted : April 30, 2018
Last Update Posted : September 4, 2019
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Adenomatous Polyp |
Interventions |
Drug: Aspirin Drug: Eflornithine Other: Laboratory Biomarker Analysis Other: Placebo Other: Telephone-Based Intervention |
Enrollment | 107 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I (Acetylsalicylic Acid and Eflornithine) | Arm II (Placebo) |
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Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO once daily on days 1-28. | Patients receive corresponding placebo PO daily on days 1-28. |
Period Title: Overall Study | ||
Started | 54 | 53 |
Completed | 49 | 49 |
Not Completed | 5 | 4 |
Reason Not Completed | ||
Cancel Prior to treatment | 1 | 3 |
Protocol Violation | 1 | 1 |
Ineligible | 3 | 0 |
Baseline Characteristics
Arm/Group Title | Arm I (Acetylsalicylic Acid and Eflornithine) | Arm II (Placebo) | Total | |
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Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28. | Patients receive corresponding placebo PO daily on days 1-28. | Total of all reporting groups | |
Overall Number of Baseline Participants | 49 | 49 | 98 | |
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All eligible patients that began protocol treatment were included in this analysis. Patients who cancelled prior to treatment, violations and ineligible patients were excluded.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 49 participants | 49 participants | 98 participants | |
62
(46 to 83)
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62
(50 to 79)
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62
(46 to 83)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 49 participants | 49 participants | 98 participants | |
Female |
26 53.1%
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19 38.8%
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45 45.9%
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Male |
23 46.9%
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30 61.2%
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53 54.1%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 49 participants | 49 participants | 98 participants |
49 100.0%
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49 100.0%
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98 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Frank A. Sinicrope, M.D. |
Organization: | Mayo Clinic |
EMail: | sinicrope.frank@mayo.edu |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00983580 |
Obsolete Identifiers: | NCT01647126 |
Other Study ID Numbers: |
NCI-2009-01192 NCI-2009-01192 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 09-001758 MC054A ( Other Identifier: Mayo Clinic ) R01CA113681 ( U.S. NIH Grant/Contract ) P30CA015083 ( U.S. NIH Grant/Contract ) |
First Submitted: | September 23, 2009 |
First Posted: | September 24, 2009 |
Results First Submitted: | February 20, 2018 |
Results First Posted: | April 30, 2018 |
Last Update Posted: | September 4, 2019 |