Ovarian Cancer Clinical Trials

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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
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Qilu Hospital of Shandong University, Sun Yat-Sen University Cancer Center, First Affiliated Hospital of Wenzhou Medical University, Ningbo Women & Children's Hospital, First Affiliated Hospital of Zhejiang University, Ningbo No. 1 Hospital, Second Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, Jiaxing Maternity and Child Health Care Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine

This content was sourced from clinicaltrials.gov