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NCT02965703Active, not recruitingPhase 2

Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
81 (actual)
First submitted
16 Nov 2016
Start date
16 Jan 2018
Primary completion date
31 Jan 2023
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT02965703

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 81
  • From 16 Jan 2018 to the primary completion date, 31 Jan 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants may not be receiving any other investigational agents
  • Women who are pregnant or breastfeeding; pregnant women are excluded from this study because aspirin has the potential for abortifacient effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin

Other illness

  • History of
    • Any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer
    • Chronic renal diseases or liver cirrhosis
    • Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease
    • Hemorrhagic stroke or uncontrolled hypertension
  • History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements

Lab values

  • Current (within three weeks of randomization) or planned use during the study intervention of the following:
    • Aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors
    • Anticoagulants, anti-platelet agents, or corticosteroids
    • Gingko
    • Ethanol consumption \> 1 standard drinks/day for women, or \> 2 standard drinks/day for men
    • Methotrexate (MTX)
    • Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)

Who the study is looking for

  • Diagnosis of colorectal adenoma of any grade
  • Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
  • Leukocytes \>= 3,000/microliter
  • Absolute neutrophil count \>= 1,500/microliter
  • Platelets \>= 150,000/microliter
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional ULN
  • Creatinine =\< 1.5 x institutional ULN
  • Blood hemoglobin \>= 12.0 g/dL
  • Alkaline phosphatase =\< 1.5 x institutional ULN
  • Blood urea nitrogen (BUN) =\< 40 mg/dL
  • Estimated glomerular filtration rate (eGFR) \>= 45 mL/min
  • Negative fecal occult blood test
  • The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vanderbilt University/Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.