Mittwoch, 28. Juli 2021
Navigation öffnen
Anzeige:
Lenvima
Lenvima
 
JOURNAL ONKOLOGIE – STUDIE
MATAO

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

Rekrutierend

NCT-Nummer:
NCT04111978

Studienbeginn:
November 2020

Letztes Update:
24.06.2021

Wirkstoff:
Letrozole 2.5mg

Indikation (Clinical Trials):
Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Endometrioid, Carcinoma

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Swiss Go Trial Group

Collaborator:
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,

Studienleiter

Viola Heinzelmann-Schwarz, Prof. MD PhD
Principal Investigator
University Hospital Basel, Head Women's Hospital

Kontakt

Studienlocations
(3 von 20)

Universitätsklinik für Medizinische Onkologie, Inselspital
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Franziska Zenger, Dr. med
Phone: +41 (0)31 632 5059
E-Mail: franziska.zenger@insel.ch
» Ansprechpartner anzeigen
Praxis im Frauenzentrum Lindenhofspital
3012 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ralf Rothmund, Prof.
Phone: +41 (0)31 300 85 80
E-Mail: ralf.rothmund@lindenhofgruppe.ch
» Ansprechpartner anzeigen
Hôpitaux Universitaires de Genève
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Intidar Labidi-Galy, Dr. med.
Phone: +41 (0)22 372 4014
E-Mail: intidhar.labidi-galy@hcuge.ch
» Ansprechpartner anzeigen
Universitätsspital Waadt/ CHUV
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Apostolos Sarivalasis, Dr. med.
Phone: +41 (0)79 556 73 62
E-Mail: apostolos.sarivalasis@chuv.ch
» Ansprechpartner anzeigen
Tumorzentrum Hirslanden Klinik St. Anna
6006 Luzern
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Andreas Günthert, Prof
Phone: +41 (0)41 208 41 13
E-Mail: Andreas.guenthert@hin.ch
» Ansprechpartner anzeigen
Kantonsspital Münsterlingen
8596 Münsterlingen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Christian Taverna, Dr. med.
Phone: +41 (0)71 686 22 02
E-Mail: christian.taverna@stgag.ch
» Ansprechpartner anzeigen
Onkozentrum Hirslanden Zürich
8032 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Anita Hirschi-Blickenstorfer, Dr. med.
Phone: +41 (0)44 387 3761
E-Mail: ahirschi@onkozentrum.ch
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely

used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer,

as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in

ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as

well. Of which low grade ovarian cancers demonstrates the highest level of expression,

supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study

be investigated prospectively and evaluated as maintenance therapy after standard surgical

and chemotherapy treatment in comparison to placebo (which is the current standard

maintenance treatment) in subjects with primary, ER-positive low or high grade serous or

endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal

cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based

chemotherapy.

The objectives are to evaluate the letrozole maintenance treatment compared to placebo in

terms of

- progression-free survival (PFS; primary endpoint)

- overall survival (OS)

- quality-adjusted progression free survival (QAPFS)

- time to first subsequent treatment (TFST)

- quality-adjusted time without symptoms of toxicity (Q-TWiST)

- health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O

questionnaires

Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized,

controlled, double-blinded, multi-centre study to either the test (letrozole) or control

(placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of

toxicity or progression of underlying disease.

Health and health-related quality of life will continuously be assessed at study entry and

during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by

every 24 weeks for the next 3 years. Procedures performed to assess the participants' health

are the same as are performed during the regular routine ovarian cancer follow-up visits:

blood tests, physical as well as gynaecological examinations and may include imaging. In

addition, the participants are asked to complete during the study quality of life (QoL)

specific questionnaires and wear an activity tracker for one week just before the scheduled

visits. These assessments will be used for the evaluation of letrozole's efficacy and burden

in comparison to the standard maintenance treatment. Survival follow-up data after the

mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) for each study group (Time Frame - Up to approximately 12 years):
PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression. Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.



Secondary outcome:

1. Overall survival (OS) for each study group (Time Frame - Up to approximately 12 years):
OS defined for each patient as the time from the date of first IMP administration until the date of death from any cause. Patients not having an event at the time of analysis will be censored at the date they were last known to be alive.

2. Quality-adjusted progression free survival (QAPFS) for each study group (Time Frame - Up to approximately 12 years):
QAPFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period. QAPFS incorporates progression-free survival (quantity) and quality of life during this period into a measure of net clinical benefit: QAPFS = PFS (years or months) x QoL (utility value). Utility values derived from the EQ-5D-L5 questionnaire will be used.

3. Time to first subsequent treatment (TFST) for each study group (Time Frame - Up to approximately 12 years):
TFST defined for each patient as the time from the date of first IMP administration until the date the patient started the next (second-line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.

4. Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group (Time Frame - Up to approximately 12 years):
Q-TWiST defined as the Quality adjusted Time Without appearance of any Symptoms of Toxicity related to either the progression of the cancer or side effects of the trial medication from the date of first IMP administration until dead. The Q-TWiST analysis considers the following three health states: (1) the period experiencing toxicity (TOX) (2) the period before progression without experiencing toxicity (TWiST) (3) the period after relapse (REL) These periods are assigned preference utilities (u), which will be derived using the generic EQ-5D-5L questionnaire. The Q-TWiST will be calculated as the weighted sum of the time spent in each health state: Q-TWiST = uTox*TOX + TWiST + uRel*REL where u denotes the assigned utility for each respective health state.

5. Health related quality of life (QoL) assessed byFunctional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire for each study group (Time Frame - Up to approximately 5.25 years):
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) is included into the study to more specifically assess the side effects from the IMPs on quality of life. The minimum value is 0, the maximum value for the specific 19 item Endocrine Symptom Subscale (ESS-19) is 76. The higher the score, the better the QOL

6. Health related quality of life (QoL) assessed by Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire for each study group (Time Frame - Up to approximately 5.25 years):
In the context of this study the specific ovarian cancer symptom-oriented questionnaire Functional Assessment of Cancer Therapy - Ovarian (FACT-O) is included to assess the progression/recurrence of ovarian cancer on Quality of Life. The minimum value is 0, the maximum value including the specific Ovarian Cancer Subscale (OCS) is 152. The higher the score, the better the QOL

Studien-Arme

  • Experimental: Letrozole (aromatase inhibitor)
    Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease
  • Placebo Comparator: Placebo
    Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease

Geprüfte Regime

  • Letrozole 2.5mg (Femara):
    Aromatase inhibitor
  • Placebo:
    Placebo tablet of Femara

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
EHA 2021
  • SCD: Häufigere und längere VOC-bedingte Krankenhausaufenthalte nach Vorgeschichte von VOC-Hospitalisierungen – Ergebnisse einer Beobachtungsstudie
  • Real-World-Daten des ERNEST-Registers untermauern Überlebensvorteil unter Ruxolitinib bei primärer und sekundärer Myelofibrose
  • I-WISh-Studie: Ärzte sehen TPO-RAs als beste Option, um anhaltende Remissionen bei ITP-Patienten zu erzielen
  • Phase-III-Studie REACH2 bei steroidrefraktärer akuter GvHD: Hohes Ansprechen auf Ruxolitinib auch nach Crossover
  • SCD: Neues digitales Schmerztagebuch zur tagesaktuellen Erfassung von VOCs wird in Beobachtungsstudie geprüft
  • Französische Real-World-Studie: Eltrombopag meist frühzeitig nach ITP-Diagnose im Rahmen eines Off-label-Use eingesetzt
  • Fortgeschrittene systemische Mastozytose: Französische Real-World-Studie bestätigt klinische Studiendaten zur Wirksamkeit von Midostaurin
  • CML-Management weitgehend leitliniengerecht, aber verbesserungsfähig – Ergebnisse einer Querschnittsbefragung bei britischen Hämatologen
  • Britische Real-World-Studie: Kardiovaskuläres Risikomanagement bei MPN-Patienten in der Primärversorgung nicht optimal
  • Myelofibrose: Früher Einsatz von Ruxolitinib unabhängig vom Ausmaß der Knochenmarkfibrose