Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• Expected survival ≥6 months

• The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)

• Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.

Locations
Other Locations
China
Sun Yat-Sen University Cancer Hospital
NOT_YET_RECRUITING
Guangzhou
Sir Run Run Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Medical College of Zhejiang University
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Medical College of Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Yaxia Chen
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Ji'nan
Ningbo women's and children's Hospital
NOT_YET_RECRUITING
Ningbo
The No, 1 People's Hospital of Ningbo
NOT_YET_RECRUITING
Ningbo
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Contact Information
Primary
Yaxia Chen, MD
chenyax@zju.edu.cn
+86-571-87061501
Backup
Yang Li, MD
li_yang@zju.edu.cn
+86-571-87061501
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 538
Treatments
Experimental: Nab-Paclitaxel/carboplatin for systemic therapy after surgery
Nab-Paclitaxel/carboplatin q3 weeks 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
Active_comparator: Paclitaxel/carboplatin for systemic therapy
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)
Related Therapeutic Areas
Ovarian Cancer
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, Qilu Hospital of Shandong University, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Ningbo Women & Children's Hospital, Sun Yat-sen University, Ningbo No. 1 Hospital, Second Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, Jiaxing Maternity and Child Health Care Hospital
Leads: Women's Hospital School Of Medicine Zhejiang University

This content was sourced from clinicaltrials.gov

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