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MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

Study acronym: MATAO
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Oct 1, 2025 to Jul 1, 2027
    • Study sites: 43 to 53
    • Study completion date: Oct 1, 2030 to Jul 1, 2032
    v11
  2. Study sites: 34 to 43v10
  3. Study sites: 32 to 34v9
  4. Study sites: 29 to 32v8
  5. Site details revised at 1 of 29 sitesv7
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  1. Site details revised at 6 of 29 sitesv6
  2. Study sites: 20 to 29v5
  3. Site details revised at 3 of 20 sitesv4
  4. Study sites: 19 to 20
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (6)
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Start date changed from estimate of Jan 1, 2020 to Nov 5, 2020
    • Study sites: 0 to 19
    • Primary completion date: Jul 1, 2025 to Oct 1, 2025
    • Study completion date: Jul 1, 2030 to Oct 1, 2030
    • Secondary endpoints revised (6)
    • Study description expanded, about 14 words
    • Collaborators: 2 to 9
    • Eligibility criteria expanded, about 1 word
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
Trial Details
NCT Number NCT04111978
Lead Sponsor Swiss GO Trial Group
Collaborators: AGO Study Group, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, Reliable Cancer Therapies, Krebsliga Schweiz, Stiftung Guido Feger, Hoffmann-La Roche, Helsana AG, Novartis Pharmaceuticals, Anticancer Fund, Belgium
Conditions
(from sponsor)		 Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms, High-grade Serous Ovarian Carcinoma (HGSOC), Low-grade Serous Ovarian Carcinoma (LGSOC), Ovarian Endometrioid Carcinoma
Related terms Fallopian Tube Neoplasms, Peritoneal Neoplasms
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov