drugset / Trial / NCT03794778
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.