PERSONALIZED MOLECULAR DRIVEN SURGERY ACCORDING TO BRCA MUTATIONAL STATUS IN ADVANCED EPITHELIAL OVARIAN CANCER PATIENTS WITH HIGH TUMOR LOAD
- Conditions
- ADVANCED OVARIAN CARCINOMAMedDRA version: 21.1Level: PTClassification code 10054913Term: Serous cystadenocarcinoma ovarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002474-30-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 210
1. Diagnosis of advanced epithelial ovarian cancer (FIGO stage III B-IV)
2. high tumor load assessed by laparoscopy according to the Fagotti’s score (PIV 8-12)
3. age between 18 and 80
4. Performance Status (ECOG) = 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula)
5. sBRCA-wt
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. FIGO stages IA-IIIA ii
2. any histology but high grade serous
3. hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater
4. history of any type of cancer in the past 5 years
5. concomitant other malignancies
6. pregnancy or lactation
7. refusal to provide written informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method