Overview
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
Status:
Recruiting
Recruiting
Trial end date:
2024-03-31
2024-03-31
Target enrollment:
0
0
Participant gender:
Female
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang UniversityTreatments:
Albumin-Bound PaclitaxelCarboplatin
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
- 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.