Trials / Recruiting
RecruitingNCT05737303
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.
Conditions
- Epithelial Ovarian Carcinoma Stage III
- Epithelial Ovarian Carcinoma Stage IV
- Fallopian Tube Carcinoma Stage III
- Fallopian Tube Carcinoma Stage IV
- Primary Peritoneal Carcinoma Stage III
- Primary Peritoneal Carcinoma Stage IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-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) |
Timeline
- Start date
- 2023-11-27
- Primary completion
- 2025-12-31
- Completion
- 2027-12-31
- First posted
- 2023-02-21
- Last updated
- 2025-02-11
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05737303. Inclusion in this directory is not an endorsement.