SalvOvar
A pragmatic randomized phase III trial to assess the utility of adjusting chemotherapy dose & dosing schedule with the SALVage weekly dose-dense regimen in patients with poor prognostic OVARian cancers based on the tumor primary chemosensitivity and incomplete debulking surgery.
PRIMARY OBJECTIVE
↪ To show benefit for OS from a densification of chemotherapy (weekly dose-dense carboplatin-paclitaxel)
compared to:
The continuation of the standard 3-weekly carboplatin-paclitaxel, in ovarian cancer patients with a poor prognostic disease after 3-4 cycles of standard NAC
↪ Poor chemosensitivity
(with an unfavorable KELIM™ score < 1.0)
& disease not amenable to complete interval debulking surgery.
Hypothesis: weekly dose-dense chemotherapy
↗ chemotherapy efficacy
↗ possibility of late debulking surgery
↗ access and efficacy of PARPi
SECONDARY OBJECTIVE
↪ Other efficacy outcomes:
ORR, PFS, % of patients operated with complete late surgery
↪ Impact of adding bevacizumab and/or PARP inhibitor on efficacy outcomes
↪ Safety of the chemotherapy densification
We would like to express our deepest gratitude to the following individuals for their invaluable contribution to the translation of the videos: Dr. Giulio Ricotta, Dr. Gwenaël Ferron, Dr. Manon Daix, Dr. Martina Ángeles Fité, Dr. Willemien Van Driel, Pr. Benoît You, and Pr. Nozomu Yanaihara.
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