Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT04111978

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

Led by Swiss GO Trial Group · Updated on 2025-09-29

540

Participants Needed

53

Research Sites

608 weeks

Total Duration

On this page

Sponsors

S

Swiss GO Trial Group

Lead Sponsor

A

AGO Study Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be ≥ 18 years of age
  • 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.
Not Eligible

You will not qualify if you...

  • Progressive disease at the end of adjuvant treatment as defined in chapter 9.2.1 of protocol
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

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

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Research Team

M

McLaughlin, PhD

CONTACT

V

Vogel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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