FIGO stage III ovarian cancer who are eligible for primary cytoreductive surgery resulting in non-residual disease, or residual disease up to 2.5 mm
Conditions
Brief summary
The primary endpoint is overall survival, defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (“last known alive date”). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up.
Detailed description
Recurrence-free survival is defined as the time between the date of randomization and the first date of documented disease progression or recurrence, as determined by the GCIG criteria (Appendix 1) , or death due to any cause, whichever occurs first (36). Disease recurrence or progression will be regularly evaluated via a standardized follow-up scheme and/or following clinical symptoms., The time to first subsequent anticancer treatment after first recurrent disease (TFST), The toxicity and morbidity will be reported until 30 days after the end of chemotherapy, using the Common Toxicity Criteria for Adverse Events (CTCAE v5.0) for all events, and using the Clavien-Dindo method for surgery-related events.
Interventions
DRUGsolution à diluer pour perfusion
DRUGSODIUM THIOSULFATE
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGPaclitaxel Eugia 6 mg/ml
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is overall survival, defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (“last known alive date”). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival is defined as the time between the date of randomization and the first date of documented disease progression or recurrence, as determined by the GCIG criteria (Appendix 1) , or death due to any cause, whichever occurs first (36). Disease recurrence or progression will be regularly evaluated via a standardized follow-up scheme and/or following clinical symptoms., The time to first subsequent anticancer treatment after first recurrent disease (TFST), The toxicity and morbidity will be reported until 30 days after the end of chemotherapy, using the Common Toxicity Criteria for Adverse Events (CTCAE v5.0) for all events, and using the Clavien-Dindo method for surgery-related events. | — |
Countries
Denmark, France, Germany, Ireland, Italy, Netherlands, Sweden
Outcome results
None listed