drugset / Trial / NCT03794778

Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer

NCT03794778

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who were histopathology or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant chemotherapy), residual disease after surgery (\>1cm, \<1cm, no primary surgery), stage (Ic, II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0 to 1 or 2), BRCA1/2 gene mutation.

Timeline

Start
2019-03-19
Primary completion
2024-03-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PLD 30 mg/m2, i.v.,d1; once every 21days Unknown 30 mg/m2
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Carboplatin Small molecule Intravenous

Indications

No indication recorded.