EXemestane in Progesterone and/or Estrogen receptor positive epithelial ovarian cancer. A Randomized phase III Trial, EXPERT.

Phase 1

• Conditions: Women with confirmed high grade serous or endometrial epithelial ovarian cancer.; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000693-30-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-16
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 468

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified