MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
NCT ID: NCT04111978
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2020-11-05
2032-07-01
Brief Summary
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The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
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Detailed Description
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The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of
* progression-free survival (PFS; primary endpoint)
* overall survival (OS)
* quality-adjusted progression free survival (QAPFS)
* time to first subsequent treatment (TFST)
* quality-adjusted time without symptoms of toxicity (Q-TWiST)
* health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires
Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease.
Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Letrozole (aromatase inhibitor)
Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease
Letrozole 2.5mg
Aromatase inhibitor
Placebo
Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease
Placebo
Placebo tablet of Femara
Interventions
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Letrozole 2.5mg
Aromatase inhibitor
Placebo
Placebo tablet of Femara
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to attend the visits and to understand all study-related procedures.
* Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer
* (Interval-) debulking performed ECOG-Performance Status 0-2
* Signed informed consents (ICF-1; ICF-2)
* Paraffin-embedded tissue or paraffin-embedded cell block (from ascites) available
* Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)
* At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
* Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.
Exclusion Criteria
* Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
* Pregnant or lactating women
* Any other malignancy within the last 5 years which has impact on the prognosis of the patient
* \< 4 cycles of chemotherapy in total
* Contraindications to endocrine therapy
* Inability or unwillingness to swallow tablets
* Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose malabsorption
18 Years
FEMALE
No
Sponsors
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AGO Study Group
OTHER
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
OTHER
Reliable Cancer Therapies
INDUSTRY
Krebsliga Schweiz
UNKNOWN
Stiftung Guido Feger
UNKNOWN
Hoffmann-La Roche
INDUSTRY
Helsana AG
UNKNOWN
Novartis Pharmaceuticals
INDUSTRY
Anticancer Fund, Belgium
OTHER
Swiss GO Trial Group
NETWORK
Responsible Party
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Principal Investigators
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Heinzelmann-Schwarz, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Head Women's Hospital
Locations
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Krankenhaus der Barmherzigen Brüder Graz
Graz, , Austria
Medizinische Universität Graz
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Landeskrankenhaus Hochsteiermark Leoben
Leoben, , Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, , Austria
Universitätsklinikum Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
Klinik Hietzing Wien
Vienna, , Austria
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, , Germany
St. Elisabeth-Krankenhaus
Cologne, , Germany
Donauisar Klinikum
Deggendorf, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Evangelische Kliniken Essen Mitte GmbH
Essen, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
The University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, , Germany
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
Hildesheim, , Germany
Klinikum Konstanz
Konstanz, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
University Hospital Münster
Münster, , Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, , Germany
SL Klinikum Rosenheim
Rosenheim, , Germany
Leopoldina Krankenhaus der Stadt Schweinfurt
Schweinfurt, , Germany
Universitätsklinik Ulm
Ulm, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, , Germany
AMO Wolfsburg / AMO MVZ GmbH
Wolfsburg, , Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, , Germany
Kantonsspital Aarau AG
Aarau, Canton of Aargau, Switzerland
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)
Bellinzona, Canton Ticino, Switzerland
Centre Hospitalier du Valais Romand
Sion, Valais, Switzerland
Kantonsspital Baden AG
Baden, , Switzerland
Basel Claraspital AG
Basel, , Switzerland
Universitätsklinik für Medizinische Onkologie, Inselspital
Bern, , Switzerland
Praxis im Frauenzentrum Lindenhofspital
Bern, , Switzerland
Kantonspital Graubünden (KSGR),
Chur, , Switzerland
Kantonsspital Frauenfeld
Frauenfeld, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Frauenklinik Spital Grabs
Grabs, , Switzerland
Universitätsspital Waadt/ CHUV
Lausanne, , Switzerland
Kantonsspital Baselland
Liestal, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Tumorzentrum Hirslanden Klinik St. Anna
Lucerne, , Switzerland
Kantonsspital Münsterlingen
Münsterlingen, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Klinik für Onkologie und Hämatologie Hirslanden Zürich AG
Zurich, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Unispital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Sevelda
Role: primary
Kolovetsiou- Kreiner MD
Role: primary
Marth
Role: primary
Peternell
Role: primary
Maderdonner
Role: backup
References
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McLaughlin PMJ, Klar M, Zwimpfer TA, Dutilh G, Vetter M, Marth C, du Bois A, Schade-Brittinger C, Reuss A, Bommer C, Kurzeder C, Heinzelmann-Schwarz V. Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial. BMC Cancer. 2022 May 6;22(1):508. doi: 10.1186/s12885-022-09555-8.
Other Identifiers
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2024-511219-78-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-002264-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ENGOT-ov54
Identifier Type: OTHER
Identifier Source: secondary_id
Swiss-GO-2
Identifier Type: OTHER
Identifier Source: secondary_id
AGO-OVAR 26
Identifier Type: OTHER
Identifier Source: secondary_id
AGO 65
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-ov54/Swiss-GO-2/MATAO
Identifier Type: -
Identifier Source: org_study_id
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