ASA in Prevention of Ovarian Cancer (STICs and STONEs)

NCT ID: NCT03480776

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2026-09-15

Brief Summary

While ASA is not a cancer medication, research suggests that taking ASA reduces the probability of getting many types of cancer because of its anti-inflammatory action. Inflammation in the ovaries during ovulation is thought to contribute to the development of ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent it.

Detailed Description

The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally.

Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken by mouth. ASA has been available for over 100 years and has been used mainly to relieve fever and pain, but also as an anti-inflammatory medication in order to reduce inflammation (swelling).

Conditions

Ovarian Cancer Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Acetylsalicylic Acid (ASA)

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type: DRUG

81 mg PO daily or 325 mg PO daily

Placebo

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: OTHER

One tablet PO daily

Interventions

Acetylsalicylic acid

81 mg PO daily or 325 mg PO daily

Intervention Type: DRUG

Placebo

One tablet PO daily

Intervention Type: OTHER

Other Intervention Names

ASA

Eligibility Criteria

Inclusion Criteria

• Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines
• Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families
• ECOG performance status 0 or 1
• Age ≥ 18 years old
• Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.
• Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate
• Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.
• In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization
• Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication

Exclusion Criteria

• Subjects with history of other malignancies, except:

• adequately treated non-melanoma skin cancer;
• curatively treated in-situ cancer of the cervix;
• previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization; endocrine therapy for breast cancer is allowed at any time.
• other solid tumours curatively treated with no evidence of disease for > 5 years.
• Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.
• Subjects with active bleeding or bleeding diathesis.
• Subjects with active peptic ulcer.
• Subjects with renal, hepatic or congestive heart failure.
• Subjects with concurrent use of anti-coagulants and/or anti-platelet agents.
• Subjects with prior bilateral salpingectomy.
• Subjects with history of chronic daily use of ASA or NSAIDs.
• Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.
• Ongoing or planned pregnancy.
• Subjects who are breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Apotex Inc.

INDUSTRY

Sponsor Role: collaborator

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Oza

Role: STUDY_CHAIR

Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

Stephanie Lheureux

Role: STUDY_CHAIR

Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

Locations

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Peter McCallum Cancer Institute

Melbourne, Victoria, Australia

King Edward Memorial Hospital

Subiaco, Western Australia, Australia

St John of God Subiaco

Subiaco, Western Australia, Australia

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Clinical Research Unit at Vancouver Coastal

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

North York General Hospital

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

CIUSSS de l'Est-de-I'lle-de-Montreal

Montreal, Quebec, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada

Countries

Australia; Canada

Other Identifiers

OV25

Identifier Type: -

Identifier Source: org_study_id