⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Viola Heinzelmann-Schwarz, Prof. MD PhD

Affiliation: University Hospital Basel, Head Women's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: