At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed high-grade epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma (serous, endometrioid, or carcinosarcoma ≥30% epithelial)
- ✓Advanced stage III or IV disease
- ✓Treated with 3 to 4 neo-adjuvant cycles of standard carboplatin-paclitaxel
- ✓Unfavorable KELIM score <1.0 indicating poor primary chemosensitivity
- ✕Low-grade endometrioid, clear cell, mucinous, sarcomatous, or borderline tumors
- ✕Contraindication to carboplatin, paclitaxel, or G-CSF
- ✕Prior bevacizumab during initial neo-adjuvant chemotherapy
- ✕Primary platinum-refractory disease (progression during neo-adjuvant chemotherapy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
In Brief
A Phase 3 clinical trial evaluating Carboplatin and Paclitaxel for Ovarian Cancer. Currently recruiting, targeting 250 participants across 72 sites in 3 countries.
Detailed Summary
SALVOVAR will be a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen.
Study Details
Timeline
Interventions
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy