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SALVOVAR trial: 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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508260-30-01
Acronym
GINECO-OV130b
Enrollment
145
Registered
2024-05-07
Start date
2024-07-30
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Patients with poor prognostic OVARian cancers based on the tumor primary chemosensitivity and incomplete debulking surgery.

Brief summary

- Percentage of patients operated with late complete debulking surgery after receiving 3 additional cycles of randomized chemotherapy (expected increase from 5% in the control arm to 20%)% in the experimental arm), - Overall survival improvement by 49% (HR = 0.61) in the whole population translating in an improvement in median OS from 20 months (control arm) to 32.8 months (experimental arm) with a 1:1 randomization

Detailed description

- Overall response rate according to RECIST V1.1 in the whole population (see appendix 4), - Progression-free survival in the whole population, - Percentage of patients treated with a subsequent maintenance treatment with a PARP inhibitor (%) in the whole population, - Progression-free survival and overall survival in these patients compared to those not treated with PARP inhibitor, - In the population of patients treated with bevacizumab: • Overall response rate according to RECIST V1.1 • Progression-free survival & overall survival according to RECIST V1.1 • Percentage of patients operated with a late complete debulking surgery (%), - Adverse events graded according to the NCI Common Terminology Criteria Adverse Event Version 5.0 (see appendix 3), - Quality of life questionnaires, - To determine the impact of patient beliefs, preferences and experiences on the decision-making process; endpoint: shared decision-making, - To determine the impact of the shared decision-making process on outcomes in the short- and medium-term; endpoints: satisfaction with care, satisfaction with decision, patient-doctor relationship, emotions, treatment beliefs, treatment adherence, and quality of life., - Percentage of patients with BRCA mutation (%), - Percentage of patients with BRCA wild-type HRD disease (%), - Percentage of patients with BRCA wild-type HRP disease (%), - Tests/assays used (names, proprietary), and percentage of each of them (%), - Incremental cost-utility ratio and incremental cost-effectiveness ratio, - Net financial impact over 5 years, - Percentage of patients operated with late complete debulking surgery, regardless of the number of chemotherapy cycles received

Interventions

DRUGCARBOPLATIN
DRUGBEVACIZUMAB
DRUGPACLITAXEL
DRUGFilgrastim HEXAL 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Sponsors

Arcagy Gineco
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- Percentage of patients operated with late complete debulking surgery after receiving 3 additional cycles of randomized chemotherapy (expected increase from 5% in the control arm to 20%)% in the experimental arm), - Overall survival improvement by 49% (HR = 0.61) in the whole population translating in an improvement in median OS from 20 months (control arm) to 32.8 months (experimental arm) with a 1:1 randomization

Secondary

MeasureTime frame
- Overall response rate according to RECIST V1.1 in the whole population (see appendix 4), - Progression-free survival in the whole population, - Percentage of patients treated with a subsequent maintenance treatment with a PARP inhibitor (%) in the whole population, - Progression-free survival and overall survival in these patients compared to those not treated with PARP inhibitor, - In the population of patients treated with bevacizumab: • Overall response rate according to RECIST V1.1 • Progression-free survival & overall survival according to RECIST V1.1 • Percentage of patients operated with a late complete debulking surgery (%), - Adverse events graded according to the NCI Common Terminology Criteria Adverse Event Version 5.0 (see appendix 3), - Quality of life questionnaires, - To determine the impact of patient beliefs, preferences and experiences on the decision-making process; endpoint: shared decision-making, - To determine the impact of the shared decision-making process on

Countries

France, Italy, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026