RecruitingPhase 3NCT05737303

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

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


Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

538 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares nab-paclitaxel (albumin-bound paclitaxel) against standard taxane chemotherapy drugs as first-line treatment for advanced ovarian, fallopian tube, or primary peritoneal cancer (stage III or IV). All of these are typically treated with carboplatin plus a taxane drug, but different formulations vary in effectiveness and side effects. The study aims to find the better option. **You may be eligible if...** - You have been diagnosed with stage III or IV epithelial ovarian, fallopian tube, or peritoneal cancer, confirmed by biopsy or cytology - You have not previously received chemotherapy or pelvic radiation for this cancer - You are in good enough health (ECOG score 0–2) and expected to live at least 6 months - Your cancer is measurable on imaging - You are willing to attend regular clinic visits and agree to participate **You may NOT be eligible if...** - Your tumour is of low malignant potential (borderline) - You have had another cancer in the last 5 years (except treated cervical carcinoma in situ or skin cancer) - You have cancer spread to the brain, or significant nerve damage (peripheral neuropathy > grade 1) - You have severe heart disease, serious heart rhythm problems, or recent blood clots or stroke (within 6 months) - You have severe liver or kidney dysfunction - You are pregnant or breastfeeding - You are allergic to paclitaxel, albumin, or carboplatin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnab-paclitaxel combined with carboplatin

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)


Locations(11)

Sun Yat-Sen University Cancer Hospital

Guangzhou, Guangdong, China

Qilu Hospital of Shandong University

Ji'nan, Shandong, China

Yaxia Chen

Hangzhou, Zhejiang, China

Sir Run Run Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Ningbo women's and children's Hospital

Ningbo, Zhejiang, China

The No, 1 People's Hospital of Ningbo

Ningbo, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

View Full Details on ClinicalTrials.gov

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NCT05737303