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

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• 18-75years old;

• Histopathologically or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer;

• According to the International Federation of Obstetrics and Gynecology (FIGO), the stage is Ic-IV;

• Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST) version 1.1, lesions can be measured, or patients' CA125 assessed according to GCIG criteria;

• Neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a wide range of lesions, who are not expected to achieve ideal cytoreductions before surgery;

• ECOG score ≤ 2;

• Expected survival time ≥ 3 months;

• LVEF ≥ 50%;

• Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;

• Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or times, or ≤ ULN 2.5times if Gilbert's syndrome are present;

• The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;

• Signed the informed consent.

Exclusion Criteria:

• Patients with low-grade malignant potential ovarian tumors;

• Patients who had previously received chemotherapy or pelvic and abdominal radiotherapy;

• Patients planning to receive abdominal or pelvic chemotherapy;

• The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current;

• Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;

• Uncontrolled systemic infection requiring anti-infective treatment;

• Allergies to chemotherapeutic drugs or their excipients or intolerant patients;

• Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;

• Researchers think it is not suitable for enrolling.