low-grade serous carcinoma of the ovary or peritoneum
Conditions
Brief summary
The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first., The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed. The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status., Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events.
Detailed description
Toxicity, Objective Tumour Response, Overall Survival, Adherence to Letrozole Maintenance Therapy, The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed., Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events.
Interventions
DRUGFemara 2.5 mg film-coated tablets
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGAnastrozole 1mg film-coated tablets
DRUGDocetaxel Pfizer 10 mg/mL concentrate for solution for infusion
DRUGExemestane 25 mg Film-coated Tablets
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first., The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed. The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status., Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Objective Tumour Response, Overall Survival, Adherence to Letrozole Maintenance Therapy, The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed., Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events. | — |
Countries
Ireland
Outcome results
None listed