Women with confirmed high grade serous or endometrial epithelial ovarian cancer. MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MESTANE - 25 MG COMPRESSE RIVESTITE 30 COMPRESSE IN BLISTER AL-PVDC/PVC-PVDC
Product Name: Exemestane
Pharmaceutical Form: Tablet
Sponsors
ENTE OSPEDALIERO OSPEDALI GALLIERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years. • Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer. • Disease stage IIB to IV according to Federation Internationale des Gynaecologistes et Obstetristes (FIGO) classification • Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. a. For patients enrolling after debulking surgery, the following conditions must be met: patient must be randomized at a maximum of 12 and not before 4 weeks after surgery. b. For patients who are candidates for neoadjuvant chemotherapy, the following conditions must be met:Stage IIB–IV documented via imaging or a core tissue (not fine needle aspiration) biopsy. • Immunoistochemically determined positivity (= 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed. • Measurable or evaluable disease confirmed by radiological imaging, or histological proven ovarian cancer in the absence of postoperatively measurable or evaluable lesions • Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2. • Written, informed consent obtained prior to any study-specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 468 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 468
Exclusion criteria
Exclusion criteria: • Previous systemic therapy for ovarian cancer. • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. • Indadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization. • Treatment with hormonal contraceptives during the previous 3 months from diagnosis. • Concurrent comorbidities, which contraindicates the administration of chemotherapy or endocrine therapy. • Pregnant or lactating patients. • Inability or unwillingness to swallow tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the superiority of exemestane over placebo in addition to the standard front line treatment in terms of progression free survival (PFS) in patients with Estrogen Receptor (ER) + and/or Progesteron Receptor (PgR) + Epithelial Ovarian Cancer (EOC).;Secondary Objective: - to test whether the percent expression of ER and PgR is predictive of the effect of exemestane on Progression Free Survival (PFS); - to test whether the addition of exemestane to the standard front line treatment can prolong Overall Survival (OS); - to evaluate objective response rate Overall Response Rate (ORR) of standard front line treatment and exemestane compared with standard front line treatment plus placebo; - to assess whether the effect of exemestane is affected by the proliferative index Ki67; - to evaluate the effect of exemestane on Quality of Life (QoL) as assessed by the Menopause QoL questionnaire (MENQOL); - to evaluate the compliance to the study treatment; - to evaluate the safety profile of the standard front line treatment and exemestane compared with the standard front line treatment plus placebo. ;Primary end point(s): The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. ;Timepoint(s) of evaluation of this end point: 36 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS, defined for each patient as the time from the date of randomization to the date of death from any cause. - ORR, defined as the number of patients who will experience a complete or partial response divided by the number of patients randomized with at least one target lesion at baseline. - Effect of exemestane on QoL as assessed by the Menopause Quality of Life questionnaire (MENQOL) questionnaire. ;Timepoint(s) of evaluation of this end point: 36 MONTHS | — |
Countries
Italy
Outcome results
None listed