At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Aspirin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial of Aspirin and Difluoromethylornithine (DFMO) in Patients at High Risk of Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Aspirin, Eflornithine, and 3 other interventions for Adenomatous Polyp. Completed, enrolled 107 participants across 3 sites.
Detailed Summary
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenomatous Polyp
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionOct 2016
Study CompletionAug 2019
TodayJul 2026
First PostedSep 24, 2009
Enrollment StartAug 20, 2009
Primary CompletionOct 7, 2016
Study CompletionAug 13, 2019
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 16.8 years ago
Interventions
Aspirindrug
Given PO
Eflornithinedrug
Given PO
Laboratory Biomarker Analysisother
Correlative study
Placeboother
Given PO
Telephone-Based Interventionother
Ancillary studies