Status:
UNKNOWN
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Efficacy and Safety
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief 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 can...
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 cl...
Eligibility Criteria
Inclusion
- 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 \<ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 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
- 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.
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT03794778
Start Date
March 19 2019
End Date
March 31 2024
Last Update
July 18 2022
Active Locations (1)
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1
Women's Hospital School Of Medicine Zhejiang University
Zhejiang, Hangzhou, China, 310006