PERSONALIZED MOLECULAR DRIVEN SURGERY ACCORDING TO BRCA MUTATIONAL STATUS IN ADVANCED EPITHELIAL OVARIAN CANCER PATIENTS WITH HIGH TUMOR LOAD

PERSONALIZED MOLECULAR DRIVEN SURGERY ACCORDING TO BRCA MUTATIONAL STATUS IN ADVANCED EPITHELIAL OVARIAN CANCER PATIENTS WITH HIGH TUMOR LOAD - NIRAMUN/NOMUN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002474-30-IT

Enrollment

210

Registered

2021-06-17

Start date

2019-12-20

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADVANCED OVARIAN CARCINOMA MedDRA version: 21.1 Level: PT Classification code 10054913 Term: Serous cystadenocarcinoma ovary System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: LYNPARZA Product Name: OLAPARIB Product Code: [L01XX46] Pharmaceutical Form: Tablet INN or Proposed INN: OLAPARIB CAS Number: 763113-22-0 Current Sponsor code: AZD 2281 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Overall, we want to find out whether up front treatments could be associated with different survival outcomes according to the BRCA mutational status. To demonstrate the efficacy of PDS versus NACT for increasing the PFS.;Secondary Objective: •Median OS •Quality of life assessment •Optimal cytoreduction rate • Time to starting second-line chemotherapy •General immune status and tumor-derived apoptotic body generation •Biomarkers •Radiomics features.;Primary end point(s): PFS;Timepoint(s) of evaluation of this end point: 5 years	—

Measure

Time frame

Main Objective: Overall, we want to find out whether up front treatments could be associated with different survival outcomes according to the BRCA mutational status. To demonstrate the efficacy of PDS versus NACT for increasing the PFS.;Secondary Objective: •Median OS •Quality of life assessment •Optimal cytoreduction rate • Time to starting second-line chemotherapy •General immune status and tumor-derived apoptotic body generation •Biomarkers •Radiomics features.;Primary end point(s): PFS;Timepoint(s) of evaluation of this end point: 5 years

—

Secondary

Measure	Time frame
Secondary end point(s): • OS • QoL • Cytoreduction rate • Time to starting second-line chemotherapy • General immune status and tumor-derived apoptotic body generation • Biomarkers • Radiomics features.;Timepoint(s) of evaluation of this end point: 5 years.	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica Fondazione Po

FONDAZIONE POLICLINICO GEMELLI

direzione.scientifica@policlinicogemelli.it0630155701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026