EUCTR2018-000693-30-ITActive, not recruitingPhase 1
EXemestane in Progesterone and/or Estrogen receptor positive epithelial ovarian cancer. A Randomized phase III Trial, EXPERT. - EXPERT
ENTE OSPEDALIERO OSPEDALI GALLIERA0 sites468 target enrollmentStarted: October 16, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 468
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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.
Investigators
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