RecruitingPhase 3NCT04111978

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

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).

Sponsor

Swiss GO Trial Group

Enrollment

540 participants

Start Date

Nov 5, 2020

Study Type

INTERVENTIONAL

Conditions

High-grade Serous Ovarian Carcinoma (HGSOC)Fallopian Tube Neoplasms Ovarian Neoplasm Epithelial Ovarian Endometrioid Carcinoma Peritoneal Neoplasms Low-grade Serous Ovarian Carcinoma (LGSOC)

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a hormone-blocking pill (an aromatase inhibitor) can help prevent ovarian cancer from coming back after surgery and chemotherapy. It targets ovarian cancers that are sensitive to the hormone estrogen. **You may be eligible if...** - You are 18 years old or older - You have been newly diagnosed with stage II–IV ovarian, fallopian tube, or peritoneal cancer (the type called serous or endometrioid) - You have had surgery to remove the tumour - Your cancer was found to be estrogen receptor-positive (at least 1%) by testing - You completed at least 4 rounds of platinum-based chemotherapy - You are not of childbearing potential (have had surgery or radiation that prevents pregnancy) **You may NOT be eligible if...** - Your cancer is still progressing after chemotherapy - You are of childbearing potential without permanent contraception - You are pregnant or breastfeeding - You have had another cancer in the last 5 years that affects your prognosis - You cannot swallow tablets Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetrozole 2.5mg

Aromatase inhibitor

OTHERPlacebo

Placebo tablet of Femara

Locations(53)

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

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NCT04111978

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