Using letrozole as maintenance therapy for ovarian cancer
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).
This study is testing if adding letrozole to standard treatment helps women with estrogen-receptor positive ovarian cancer live longer without their cancer getting worse after surgery and chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Swiss GO Trial Group Research network |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 53 sites (Graz and 52 other locations) |
| Trial ID | NCT04111978 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding letrozole, an aromatase inhibitor, to standard maintenance therapy for patients with estrogen-receptor positive high and low grade epithelial ovarian cancer after initial surgery and chemotherapy. Participants will be randomly assigned to receive either letrozole or a placebo to determine if letrozole improves progression-free survival compared to standard treatment. The study aims to assess various outcomes, including overall survival and quality of life, using validated questionnaires. A total of 540 eligible subjects will be enrolled in this Phase 3 trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with newly diagnosed, histologically confirmed FIGO Stage II to IV estrogen-receptor positive epithelial ovarian, fallopian tube, or peritoneal cancer.
Not a fit: Patients with progressive disease at the end of adjuvant treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with estrogen-receptor positive ovarian cancer.
How similar studies have performed: Previous studies have shown positive outcomes with aromatase inhibitors in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Graz and 52 other locations
- Krankenhaus der Barmherzigen Brüder Graz — Graz, Austria (Recruiting)
- Medizinische Universität Graz — Graz, Austria (Recruiting)
- Medizinische Universität Innsbruck — Innsbruck, Austria (Recruiting)
- Landeskrankenhaus Hochsteiermark Leoben — Leoben, Austria (Recruiting)
- Ordensklinikum Linz Barmherzige Schwestern — Linz, Austria (Recruiting)
- Universitätsklinikum Salzburg — Salzburg, Austria (Recruiting)
- Medizinische Universität Wien — Vienna, Austria (Recruiting)
- Klinik Hietzing Wien — Vienna, Austria (Recruiting)
- Charité - Universitätsmedizin Berlin Campus Virchow Klinikum — Berlin, Germany (Recruiting)
- St. Elisabeth-Krankenhaus — Cologne, Germany (Recruiting)
- Donauisar Klinikum — Deggendorf, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Active_not_recruiting)
- Evangelisches Krankenhaus Düsseldorf — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Evangelische Kliniken Essen Mitte GmbH — Essen, Germany (Recruiting)
- Klinikum Esslingen — Esslingen am Neckar, Germany (Recruiting)
- University Hospital Freiburg — Freiburg im Breisgau, Germany (Recruiting)
- The University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Agaplesion Diakonieklinikum Hamburg — Hamburg, Germany (Recruiting)
- Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard — Hildesheim, Germany (Recruiting)
- Klinikum Konstanz — Konstanz, Germany (Recruiting)
- Universitätsmedizin Mainz — Mainz, Germany (Recruiting)
- Universitätsklinikum Mannheim — Mannheim, Germany (Recruiting)
- University Hospital Münster — Münster, Germany (Recruiting)
- Studienzentrum Onkologie Ravensburg — Ravensburg, Germany (Recruiting)
- SL Klinikum Rosenheim — Rosenheim, Germany (Active_not_recruiting)
- Leopoldina Krankenhaus der Stadt Schweinfurt — Schweinfurt, Germany (Recruiting)
- Universitätsklinik Ulm — Ulm, Germany (Recruiting)
- Helios Dr. Horst Schmidt Kliniken Wiesbaden — Wiesbaden, Germany (Recruiting)
- AMO Wolfsburg / AMO MVZ GmbH — Wolfsburg, Germany (Recruiting)
- Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (Recruiting)
- Kantonsspital Aarau AG — Aarau, Canton of Aargau, Switzerland (Recruiting)
- Universitätsspital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
- Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC) — Bellinzona, Canton Ticino, Switzerland (Recruiting)
- Centre Hospitalier du Valais Romand — Sion, Valais, Switzerland (Recruiting)
- Kantonsspital Baden AG — Baden, Switzerland (Recruiting)
- Basel Claraspital AG — Basel, Switzerland (Recruiting)
- Universitätsklinik für Medizinische Onkologie, Inselspital — Bern, Switzerland (Recruiting)
- Praxis im Frauenzentrum Lindenhofspital — Bern, Switzerland (Recruiting)
- Kantonspital Graubünden (KSGR), — Chur, Switzerland (Recruiting)
- Kantonsspital Frauenfeld — Frauenfeld, Switzerland (Recruiting)
- Hôpitaux Universitaires de Genève — Geneva, Switzerland (Recruiting)
- Frauenklinik Spital Grabs — Grabs, Switzerland (Recruiting)
- Universitätsspital Waadt/ CHUV — Lausanne, Switzerland (Recruiting)
- Kantonsspital Baselland — Liestal, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- Tumorzentrum Hirslanden Klinik St. Anna — Lucerne, Switzerland (Recruiting)
- Kantonsspital Münsterlingen — Münsterlingen, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
+3 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Heinzelmann-Schwarz, Prof. MD PhD — University Hospital Basel, Head Women's Hospital
- Study coordinator: McLaughlin, PhD
- Email: mclaughlin@swiss-go.ch
- Phone: +41 61 328 42 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.