MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer

Phase 3

Recruiting

Conditions: epithelial ovarian cancer

Registration Number: 2024-511219-78-00

Lead Sponsor: Swiss GO Trial Group

Brief Summary: To evaluate the efficacy of letrozole maintenance therapy after standard surgical and chemotherapy treatment as measured by Progression Free Survival (PFS) compared to no maintenance therapy (placebo)

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

Patients must be ≥ 18 years of age

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.

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)

Exclusion Criteria

Progressive disease at the end of adjuvant treatment

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 mal-absorption

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.		The primary outcome is Progression-Free Survival (PFS), defined as the time from randomization until the date of progression (recurrence) or death by any cause in the absence of progression.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause.		Overall Survival (OS), defined for each patient as the time from randomization until the date of death from any cause.
Quality-Adjusted Progression Free Survival (QAPFS), defined as the time from randomization 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.		Quality-Adjusted Progression Free Survival (QAPFS), defined as the time from randomization 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.
Time until First Subsequent Therapy (TFST), defined for each patient as the time from randomization 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.		Time until First Subsequent Therapy (TFST), defined for each patient as the time from randomization 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.
Quality adjusted Time Without appearance of any Symptoms and Toxicity (Q-TWiST), related to either the progression of the cancer or side effects of the trial medication from randomization until death.		Quality adjusted Time Without appearance of any Symptoms and Toxicity (Q-TWiST), related to either the progression of the cancer or side effects of the trial medication from randomization until death.

Trial Locations

Locations (32): Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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Dresden, Germany
University Medical Center Hamburg-Eppendorf
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Hamburg, Germany
Klinikum Esslingen GmbH
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Esslingen Am Neckar, Germany
Universitaetsklinikum Duesseldorf AöR
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Duesseldorf, Germany
Studienzentrum Onkologie Ravensburg GmbH
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Ravensburg, Germany
Medical Center - University Of Freiburg
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Freiburg Im Breisgau, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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Mainz, Germany
Universitaetsklinikum Mannheim GmbH
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Mannheim, Germany
Agaplesion Diakonieklinikum Hamburg gGmbH
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Hamburg, Germany
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Charite Universitaetsmedizin Berlin KöR
🇩🇪Berlin, Germany
Radoslav Chekerov
Site contact
+4930450664399
radoslav.chekerov@charite.de

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