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Brief Title: MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
Official Title: 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).
Study ID: NCT04111978
Brief 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).
Detailed Description: Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, Wien, , Austria
Klinik Hietzing Wien, Wien, , Austria
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum, Berlin, , Germany
Donauisar Klinikum, Deggendorf, , Germany
Evangelisches Krankenhaus Düsseldorf, Düsseldorf, , Germany
Evangelische Kliniken Essen Mitte GmbH, Essen, , Germany
Klinikum Esslingen, Esslingen, , Germany
University Hospital Freiburg, Freiburg, , Germany
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard, Hildesheim, , Germany
Klinikum Konstanz, Konstanz, , Germany
St. Elisabeth-Krankenhaus, Köln, , Germany
University Hospital Münster, Münster, , Germany
Studienzentrum Onkologie Ravensburg, Ravensburg, , Germany
Leopoldina Krankenhaus der Stadt Schweinfurt, Schweinfurt, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, , Germany
AMO Wolfsburg / AMO MVZ GmbH, Wolfsburg, , Germany
Universitätsspital Basel, Basel, Basel Stadt, Switzerland
Kantonsspital Aarau AG, Aarau, Kanton Aargau, Switzerland
Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC), Bellinzona, Ticino, 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, Luzern, , Switzerland
Tumorzentrum Hirslanden Klinik St. Anna, Luzern, , Switzerland
Kantonsspital Münsterlingen, Münsterlingen, , Switzerland
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Klinik für Onkologie und Hämatologie Hirslanden Zürich AG, Zürich, , Switzerland
Stadtspital Triemli, Zürich, , Switzerland
Unispital Zürich, Zürich, , Switzerland
Name: Viola Heinzelmann-Schwarz, Prof. MD PhD
Affiliation: University Hospital Basel, Head Women's Hospital
Role: PRINCIPAL_INVESTIGATOR