Status:
ACTIVE_NOT_RECRUITING
ASA in Prevention of Ovarian Cancer (STICs and STONEs)
Lead Sponsor:
Canadian Cancer Trials Group
Collaborating Sponsors:
Apotex Inc.
Conditions:
Ovarian Cancer Prevention
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 dur...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2026
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03480776
Start Date
July 24 2018
End Date
September 15 2026
Last Update
March 5 2025
Active Locations (17)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
4
Peter McCallum Cancer Institute
Melbourne, Victoria, Australia, 3002