Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWomen's Hospital School Of Medicine Zhejiang University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • nab-paclitaxel combined with carboplatin

    Drug

    Nab-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

538 Participants
are divided into 2 treatment groups
Group A: Nab-Paclitaxel/carboplatin for systemic therapy after surgeryExperimental treatment 1 intervention
Group B: Paclitaxel/carboplatin for systemic therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival

Disease progression as first failure

Time frame
20 months

Secondary outcomes

1

Objective Remission Rate

The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.

Time frame
12 months
2

Survival

Overall survival (all-cause death)

Time frame
3 years, 5 years
3

Adverse events

Treatment-related symptoms

Time frame
3 years, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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