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:
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
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.
The partners are spread across Europe.
Organization of the European multi-disciplinary clinical project
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.
The trial design plans that 685 patients with advanced ovarian cancer treated with standard neo-adjuvant chemotherapy to randomize to 240 patients.
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.
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™