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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Aarau, Basilea, Bellinzona, Berna, Chur, Ginevra, Losanna, Lugano, Luzern, Sion, San Gallo, Winterthur, Zurigo, Altro
(BASEC)
Baden, Frauenfeld, Grabs, Liestal, Münsterlingen, Thun
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr Pamela McLaughlin
+41 61 328 42 04
info@clutterswiss-go.ch(BASEC)
Informazioni generali
University Hospital Basel, Head Women's Hospital,
+41 61 328 42 04
info@clutterswiss-go.ch(ICTRP)
Informazioni scientifiche
University Hospital Basel, Head Women's Hospital,
+41 61 328 42 04
info@clutterswiss-go.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
14.07.2020
(BASEC)
ID di studio ICTRP
NCT04111978 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
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)
Titolo pubblico
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) (ICTRP)
Malattie studiate
Ovarian Neoplasm Epithelial;Fallopian Tube Neoplasms;Peritoneal Neoplasms;High-grade Serous Ovarian Carcinoma (HGSOC);Low-grade Serous Ovarian Carcinoma (LGSOC);Ovarian Endometrioid Carcinoma (ICTRP)
Intervento studiato
Drug: Letrozole 2.5mg;Other: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
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)
Contatti aggiuntivi
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)
ID secondari
2019-002264-27, ENGOT-ov54, Swiss-GO-2, ENGOT-ov54/Swiss-GO-2/MATAO (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT04111978 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile