MATAO: Maintenance Therapy/Conservation Therapy with Aromatase Inhibitors for Patients with Epithelial Ovarian Carcinoma: a Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study. (ENGOT-ov54/Swiss-GO-2/MATAO)
Zusammenfassung der Studie
Femara (Letrozole) is a well-studied medication and has been approved by regulatory authorities for patients with breast cancer for 15 years. Letrozole belongs to the class of aromatase inhibitors. It blocks the production of the female steroid hormone estrogen, which promotes the growth of estrogen receptor-positive cancer cells. By taking one tablet of Letrozole (2.5 mg) daily, endogenous estrogen is reduced by 95%, which can suppress the growth of cancer cells in patients with recurrence. Estrogen receptors can also frequently be detected on the tumor surface in ovarian cancer. Therefore, Letrozole may also be a potentially suitable medication for women with ovarian cancer. The MATAO study is a drug study that investigates the efficacy of Letrozole on tumor growth in estrogen receptor-positive ovarian cancer and the prevention of recurrence. The time span between the start of the clinical study and the possible progression of the disease is evaluated as the primary endpoint. A total of around 540 participants in Germany, Austria, and Switzerland are to be included in the study. For Switzerland alone, approximately 240 participants are planned. 50% of the patients will receive treatment with Letrozole and 50% of the patients will receive a placebo without active substance. Random allocation is performed by a computer program, and neither the participant nor the treatment team knows who receives the study drug Letrozole or placebo.
(BASEC)
Untersuchte Intervention
The treatment phase of the study lasts a maximum of 5 years. Due to the study design, each patient receives the study drug for at least 1.5 years, regardless of the time of inclusion. The dose of Letrozole of 2.5 mg per day in the study corresponds to the usual dosage for breast cancer treatment.
- Test: Letrozole (Aromatase Inhibitor)
Letrozole (Femara), 2.5 mg tablet, administered once daily for a maximum of 5 years.
- Control: Placebo (standard maintenance therapy is currently "no therapy")
Placebo tablet of Femara (without aromatase inhibitor), 0.0 mg tablet, administered once daily for a maximum of 5 years.
The study visits are each linked to regular follow-up visits. The visits occur every 3 months during the first two years, then every 6 months in the following 3 years.
As part of routine follow-up, a physical and gynecological examination will be performed as well as blood tests, laboratory values including liver values, electrolytes, kidney values, and the tumor marker CA-125.
Additionally, participants will be regularly asked to complete questionnaires and wear an activity tracker one week before the scheduled visits. This aims to assess the quality of life of participants and any potential side effects of the medication.
(BASEC)
Untersuchte Krankheit(en)
Primary disease of epithelial ovarian, fallopian tube, or peritoneal cancer
(BASEC)
- ≥18 years and primary, newly diagnosed FIGO stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian, fallopian tube and peritoneum cancers. - Positive detection of estrogen receptor-positive tumor cells (proportion ≥ 1%). - Shrinkage or removal of the tumor by gynecological-oncological surgery and at least 4 cycles of platinum-based chemotherapy. (BASEC)
Ausschlusskriterien
- Progression of the disease at the end of the completed (adjuvant) treatment. - Any other malignant tumor disease within the last 5 years that could have an impact on the patient's prognosis. - Women of childbearing potential who have been opted for "fertility preservation" and do not use double contraceptive methods, as well as pregnant and breastfeeding women (BASEC)
Studienstandort
Aarau, Basel, Bellinzona, Bern, Chur, Genf, Lausanne, Lugano, Luzern, Sion, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Baden, Frauenfeld, Grabs, Liestal, Münsterlingen, Thun
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
University Hospital Basel, Head Women's Hospital,
+41 61 328 42 04
info@clutterswiss-go.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital Basel, Head Women's Hospital,
+41 61 328 42 04
info@clutterswiss-go.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.07.2020
(BASEC)
ICTRP Studien-ID
NCT04111978 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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). (ICTRP)
Öffentlicher Titel
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) (ICTRP)
Untersuchte Krankheit(en)
Ovarian Neoplasm Epithelial;Fallopian Tube Neoplasms;Peritoneal Neoplasms;High-grade Serous Ovarian Carcinoma (HGSOC);Low-grade Serous Ovarian Carcinoma (LGSOC);Ovarian Endometrioid Carcinoma (ICTRP)
Untersuchte Intervention
Drug: Letrozole 2.5mg;Other: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Progression-free survival (PFS) for each study group (ICTRP)
Overall survival (OS) for each study group;Quality-adjusted progression free survival (QAPFS) for each study group;Time to first subsequent treatment (TFST) for each study group;Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group;Health related quality of life (QoL) assessed byFunctional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire for each study group;Health related quality of life (QoL) assessed by Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire for each study group (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
AGO Study Group;Arbeitsgemeinschaft Gynaekologische Onkologie Austria;Reliable Cancer Therapies;Krebsliga Schweiz;Stiftung Guido Feger;Hoffmann-La Roche;Helsana AG;Novartis Pharmaceuticals;Anticancer Fund, Belgium (ICTRP)
Weitere Kontakte
Viola Heinzelmann-Schwarz, Prof. MD PhD;Pamela McLaughlin, PhD, pamela.mclaughlin@usb.ch, +41 61 328 42 04, University Hospital Basel, Head Women's Hospital, (ICTRP)
Sekundäre IDs
2019-002264-27, ENGOT-ov54, Swiss-GO-2, ENGOT-ov54/Swiss-GO-2/MATAO (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT04111978 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar