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ASA in Prevention of Ovarian Cancer (STICs and STONEs)

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ClinicalTrials.gov Identifier: NCT03480776
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
Apotex Inc.
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE April 6, 2018
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire [ Time Frame: 5 years ]
  • Compliance of taking ASA by serum monitoring [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2018)
  • Compliance of taking ASA by evaluation of treatment completion rates [ Time Frame: 5 years ]
  • Compliance of taking ASA by reasons for early discontinuation of protocol intervention. [ Time Frame: 5 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE ASA in Prevention of Ovarian Cancer (STICs and STONEs)
Official Title  ICMJE 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)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Ovarian Cancer Prevention
Intervention  ICMJE
  • Drug: Acetylsalicylic acid
    81 mg PO daily or 325 mg PO daily
    Other Name: ASA
  • Other: Placebo
    One tablet PO daily
Study Arms  ICMJE
  • Active Comparator: Acetylsalicylic Acid (ASA)
    Intervention: Drug: Acetylsalicylic acid
  • Sham Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca
Listed Location Countries  ICMJE Australia,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480776
Other Study ID Numbers  ICMJE OV25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE Apotex Inc.
Investigators  ICMJE
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
PRS Account Canadian Cancer Trials Group
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP