Actively Recruiting
Led by Swiss GO Trial Group · Updated on 2025-09-29
540
Participants Needed
53
Research Sites
261 weeks
Total Duration
S
Swiss GO Trial Group
Lead Sponsor
A
AGO Study Group
Collaborating Sponsor
Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor (ER) positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer (LOGOS). Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.
CONDITIONS
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive maintenance therapy with either letrozole or placebo for up to 5 years or until symptoms of toxicity or disease progression.
Routine follow-up visits every 12 weeks for the first 2 years, then every 24 weeks for the next 3 years
Duration - Up to 7 years
After maintenance treatment ends, participants are followed for survival outcomes and quality of life for up to 7 additional years.
Visits occur during routine ovarian cancer follow-up care; exact schedule may vary
Total: 53 locations
1
Krankenhaus der Barmherzigen Brüder Graz
Graz, Austria, 8020
Actively Recruiting
2
Medizinische Universität Graz
Graz, Austria, 8036
Actively Recruiting
3
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
4
Landeskrankenhaus Hochsteiermark Leoben
Leoben, Austria, 8700
Actively Recruiting
5
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria, 4010
Actively Recruiting
6
Universitätsklinikum Salzburg
Salzburg, Austria, 5020
Actively Recruiting
7
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
8
Klinik Hietzing Wien
Vienna, Austria, 1130
Actively Recruiting
9
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
10
St. Elisabeth-Krankenhaus
Cologne, Germany, 50935
Actively Recruiting
11
Donauisar Klinikum
Deggendorf, Germany, 94469
Actively Recruiting
12
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Active, Not Recruiting
13
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
Actively Recruiting
14
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
15
Evangelische Kliniken Essen Mitte GmbH
Essen, Germany, 45136
Actively Recruiting
16
Klinikum Esslingen
Esslingen am Neckar, Germany, 73730
Actively Recruiting
17
University Hospital Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
18
The University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
19
Agaplesion Diakonieklinikum Hamburg
Hamburg, Germany, 20259
Actively Recruiting
20
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
Hildesheim, Germany, 31134
Actively Recruiting
21
Klinikum Konstanz
Konstanz, Germany, 78464
Actively Recruiting
22
Universitätsmedizin Mainz
Mainz, Germany, 55131
Actively Recruiting
23
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
24
University Hospital Münster
Münster, Germany, 48149
Actively Recruiting
25
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany, 88212
Actively Recruiting
26
SL Klinikum Rosenheim
Rosenheim, Germany, 83022
Active, Not Recruiting
27
Leopoldina Krankenhaus der Stadt Schweinfurt
Schweinfurt, Germany, 97422
Actively Recruiting
28
Universitätsklinik Ulm
Ulm, Germany, 89075
Actively Recruiting
29
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany, 65199
Actively Recruiting
30
AMO Wolfsburg / AMO MVZ GmbH
Wolfsburg, Germany, 38440
Actively Recruiting
31
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42117
Actively Recruiting
32
Kantonsspital Aarau AG
Aarau, Canton of Aargau, Switzerland, 5001
Actively Recruiting
33
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
34
Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
35
Centre Hospitalier du Valais Romand
Sion, Valais, Switzerland
Actively Recruiting
36
Kantonsspital Baden AG
Baden, Switzerland, 5404
Actively Recruiting
37
Basel Claraspital AG
Basel, Switzerland, 4002
Actively Recruiting
38
Universitätsklinik für Medizinische Onkologie, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
39
Praxis im Frauenzentrum Lindenhofspital
Bern, Switzerland, 3012
Actively Recruiting
40
Kantonspital Graubünden (KSGR),
Chur, Switzerland, 7000
Actively Recruiting
41
Kantonsspital Frauenfeld
Frauenfeld, Switzerland, 8501
Actively Recruiting
42
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
43
Frauenklinik Spital Grabs
Grabs, Switzerland, 9472
Actively Recruiting
44
Universitätsspital Waadt/ CHUV
Lausanne, Switzerland, 1011
Actively Recruiting
45
Kantonsspital Baselland
Liestal, Switzerland, 4410
Actively Recruiting
46
Luzerner Kantonsspital
Lucerne, Switzerland, 6000
Actively Recruiting
47
Tumorzentrum Hirslanden Klinik St. Anna
Lucerne, Switzerland, 6006
Actively Recruiting
48
Kantonsspital Münsterlingen
Münsterlingen, Switzerland, 8596
Actively Recruiting
49
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
50
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
51
Klinik für Onkologie und Hämatologie Hirslanden Zürich AG
Zurich, Switzerland, 8032
Actively Recruiting
52
Stadtspital Triemli
Zurich, Switzerland, 8063
Actively Recruiting
53
Unispital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
M
McLaughlin, PhD
V
Vogel, PhD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Pamela M J McLaughlin, Maximilian Klar, Tibor A Zwimpfer...
https://pubmed.ncbi.nlm.nih.gov/35524184