Patients with poor prognostic OVARian cancers based on the tumor primary chemosensitivity and incomplete debulking surgery.
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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