SalvOvar

The SalvOvar project is a large European project based on the implementation of a pragmatic clinical trial, led in real-life conditions. It has several aims:

1

To propose some practical and affordable diagnostic tools for identifying the group of ovarian patients who have a very poor prognosis due to a refractory disease in first-line setting

2

To assess the utility, acceptability and affordability of therapeutic solutions based on early adjustments of their medical-and-surgical treatment, that may improve their survival.

The standard medical-and-surgical treatment of ovarian carcinoma patients relies on a systemic chemotherapy (carboplatin-paclitaxel), a tumor debulking surgery meant to be complete (no post-operative residual lesion), and a subsequent maintenance treatment with modern targeted agents. Among patients with ovarian carcinoma, a subgroup of women have a poor prognosis (5-year overall survival <20%) because their disease is characterized by a poor chemosensitivity (assessable online with the numeric CA-125 KELIM™ score <1.0), and is found non-resectable after 3-4 cycles of chemotherapy. There is high uncertainty about the best treatment adjustments for these patients.

Consortium

The partners are spread across Europe.

Work Packages

Organization of the European multi-disciplinary clinical project

Clinical Trial

ARCAGY-GINECO in collaboration with the European Network of Gynaecological Oncological Trial groups (ENGOT) will sponsor and organize the multi-center European phase III clinical trials.

Trial coordination
ARCAGY-GINECO
Website

Trial Design

The trial design plans that 685 patients with advanced ovarian cancer treated with standard neo-adjuvant chemotherapy to randomize to 240 patients.

Co-primary endpoints

  • Benefit in overall survival with  HR = 0,61 (mOS from 20.0 to 32.8 months)
  • Increase in the feasibility of late complete debulking surgery
    (from 5% to 20%)

Secondary endpoints

  • Safety
  • Radiological response rate
  • Rate of patients benefiting from PARPi and/or bevacizumab as maintenance treatment

Stratification

  • BRCA mutation: « Yes », vs « No/Unknown » 
  • KELIM: « Very unfavorable < 0.7 », vs « Moderately unfavorable 0.7-1.0 »
  • Bevacizumab, planned administration: « Yes », vs « No »
European Commission Logo

European Research Grant

The European Union (EU) has built a portfolio of projects that address the goal of the Cancer Mission. SALVOVAR is one of 12 projects chosen as part of the “Diagnosis and Treatment” cluster.

Learn more

Biomarker-Kinetics.org

A free online academic numeric tool to identify patients with a poor chemosensitive disease. KELIM™ score calculation is based on the longitudinal kinetics of the blood concentrations of the serum tumor marker CA-125 (≥ 3 values) during the first 100 days of chemotherapy.

Compute KELIM™
European Commission Logo

This project has received funding by the European Union's HORIZON-MISS-CANCER-2022-01 research program under project number 101104469