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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
538
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)
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University
Ji'nan, Shandong, China
NOT_YET_RECRUITINGYaxia Chen
Hangzhou, Zhejiang, China
RECRUITINGSir Run Run Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGNingbo women's and children's Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGThe No, 1 People's Hospital of Ningbo
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
NOT_YET_RECRUITING...and 1 more locations
Progression Free Survival
Disease progression as first failure
Time frame: 20 months
Objective Remission Rate
The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.
Time frame: 12 months
Survival
Overall survival (all-cause death)
Time frame: 3 years, 5 years
Adverse events
Treatment-related symptoms
Time frame: 3 years, 5 years
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