advanced (FIGO stage IIIA, fallopian tube cancer, IIIB, IIIC, or IV of the 2014 FIGO classification) HRDpositive high-grade ovarian cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking
Conditions
Brief summary
RFS (Recurrence free survival, defined as time from treatment randomization to the earliest date of assessment of first relapse or death by any cause)
Detailed description
Overall survival (OS) (time to event and rate at 3 and 5 years), Time to first subsequent treatment (TFST), TWIST (Time Without Symptoms of disease progression or Toxicity of treatment) at baseline, 3, 6, and 12 months, PFS2 (Time from randomization until the date of second objective disease progression or death by any cause), PROs (EORTC QLQ-C30 and EORTC QLQ-OV28), Safety assessment includes AEs/SAEs, laboratory evaluations, vital signs and physical examination, Cost effectiveness
Interventions
Sponsors
Nord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS (Recurrence free survival, defined as time from treatment randomization to the earliest date of assessment of first relapse or death by any cause) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) (time to event and rate at 3 and 5 years), Time to first subsequent treatment (TFST), TWIST (Time Without Symptoms of disease progression or Toxicity of treatment) at baseline, 3, 6, and 12 months, PFS2 (Time from randomization until the date of second objective disease progression or death by any cause), PROs (EORTC QLQ-C30 and EORTC QLQ-OV28), Safety assessment includes AEs/SAEs, laboratory evaluations, vital signs and physical examination, Cost effectiveness | — |
Countries
Austria, Belgium, Czechia, Germany, Italy, Spain
Outcome results
None listed