About this trial
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO(International Federation of Gynecology and Obstetrics)stage
Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
Written informed consent
Disqualifiers
Patients with low malignant potential ovarian tumors;
Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
Trial design
Parallel
Treatments tested in this trial
nab-paclitaxel combined with carboplatin
DrugNab-Paclitaxel/carboplatin q3weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC(area under the curve) 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC(area under the curve)2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles Paclitaxel 175 mg/m² IV followed by carboplatin AUC(area under the curve)5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC(area under the curve)2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)
Treatment groups
Trial outcomes
Primary outcomes
Progression Free Survival
Disease progression as first failure
Secondary outcomes
Objective Remission Rate
The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.
Survival
Overall survival (all-cause death)
Adverse events
Treatment-related symptoms
Sponsors and contacts
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Jiaxing Maternity and Child Health Care Hospital
Collaborator
Zhejiang University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Qilu Hospital of Shandong University
Collaborator
Ningbo No. 1 Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator