ASA in Prevention of Ovarian Cancer (STICs and STONEs)
Klíčová slova
Abstraktní
Popis
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).
Termíny
| Poslední ověření: | 03/31/2020 |
| První předloženo: | 03/13/2018 |
| Odhadovaná registrace vložena: | 03/20/2018 |
| První zveřejnění: | 03/28/2018 |
| Poslední aktualizace byla odeslána: | 07/12/2020 |
| Poslední aktualizace zveřejněna: | 07/13/2020 |
| Aktuální datum zahájení studie: | 04/05/2018 |
| Odhadované datum dokončení primární: | 03/30/2023 |
| Odhadované datum dokončení studie: | 12/30/2023 |
Stav nebo nemoc
Intervence / léčba
Drug: Acetylsalicylic Acid (ASA)
Other: Placebo
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Active Comparator: Acetylsalicylic Acid (ASA) | Drug: Acetylsalicylic Acid (ASA) 81 mg PO daily or 325 mg PO daily |
| Sham Comparator: Placebo | Other: Placebo One tablet PO daily |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | Female |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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. |
Výsledek
Primární výsledná opatření
1. Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test [5 years]
Měření sekundárních výsledků
1. Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire [5 years]
2. Compliance of taking ASA by serum monitoring [5 years]
Další výsledková opatření
1. Compliance of taking ASA by evaluation of treatment completion rates [5 years]
2. Compliance of taking ASA by reasons for early discontinuation of protocol intervention. [5 years]
