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Trial record 1 of 1 for:    OV25
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ASA in Prevention of Ovarian Cancer (STICs and STONEs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03480776
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 1, 2020
Apotex Inc.
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Prevention Drug: Acetylsalicylic acid Other: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women With BRCA 1/2 Mutations (STICs and STONEs)
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Acetylsalicylic Acid (ASA) Drug: Acetylsalicylic acid
81 mg PO daily or 325 mg PO daily
Other Name: ASA

Sham Comparator: Placebo Other: Placebo
One tablet PO daily

Primary Outcome Measures :
  1. Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire [ Time Frame: 5 years ]
  2. Compliance of taking ASA by serum monitoring [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Compliance of taking ASA by evaluation of treatment completion rates [ Time Frame: 5 years ]
  2. Compliance of taking ASA by reasons for early discontinuation of protocol intervention. [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03480776

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Contact: Wendy Parulekar 613-533-6430

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Australia, New South Wales
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Michael Friedlander    29 382-2585      
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Alison Brand         
Australia, Victoria
Peter McCallum Cancer Institute Recruiting
Melbourne, Victoria, Australia, 3002
Contact: Kelly Phillips         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Prafull Ghatage    403 521-3721      
Canada, British Columbia
Clinical Research Unit at Vancouver Coastal Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Harinder Brar    604 877-6000      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Christine Robinson    204 787-3684      
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lesa Dawson    709 777-2943      
Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Josee-Lyne Ethier    613 549-6666 ext 4502      
North York General Hospital Recruiting
Toronto, Ontario, Canada, M2K 1E1
Contact: Elyse Lackie    416 756-6704      
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Marcus Bernardini    416 946-4501 ext 2668      
Canada, Quebec
CIUSSS de l'Est-de-I'lle-de-Montreal Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Suzanne Fortin    514 252-3400 ext 4495      
CHUM-Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Diane Provencher    514 890-8444      
The Jewish General Hospital Suspended
Montreal, Quebec, Canada, H3T 1E2
Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Marie Plante    418 691-5392      
CIUSSS de l'Estrie - Centre hospitalier Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Paul Bessette    819 346-1110 ext 13120      
Sponsors and Collaborators
Canadian Cancer Trials Group
Apotex Inc.
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Study Chair: Amit Oza Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Study Chair: Stephanie Lheureux Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

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Responsible Party: Canadian Cancer Trials Group Identifier: NCT03480776    
Other Study ID Numbers: OV25
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors