NCT03794778

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

Evaluation of PEGylated Doxorubicin Hydrochloride Liposome Injection(Duomeisu®) Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer: A Randomized, Open, Multicenter Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will receive one of two treatment regimens: Group A: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin AUC 5 (dosed according to the Calvert formula, with creatinine clearance estimated according to the Cockcroftformula), intravenous infusion, d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage. Group B: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin AUC 5, intravenous infusion, d1; once every 21days, 3\~6 cycles for early stage patients and 6 cycles for late stage. Treatment was initially administered for three cycles, and patients with stable or responding disease continued treatment for further a three cycles. The main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus carboplatin in the first-line treatment of epithelial ovarian cancer. The primary endpoint is progression free survival (PFS), the secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR):CR+PR+SD, the incidence and severity of adverse reactions and health-related quality of life (HQL) assessment.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin	PLD 30 mg/m2, i.v.,d1; once every 21days
DRUG	paclitaxel	paclitaxel 175 mg/m2, i.v.,d1; once every 21days
DRUG	Carboplatin	carboplatin AUC 5, i.v.,d1; once every 21days,

Timeline

• Start date: 2019-03-19
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2019-01-07
• Last updated: 2022-07-18

Locations

1 site across 1 country: China