Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients with Advanced Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 538
- 试验地点
- 11
- 主要终点
- Progression Free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with low malignant potential ovarian tumors;
- •Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- •Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
- •Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
- •Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
- •Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA（New York Heart Association） criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicated by color Doppler ultrasonography;
- •Uncontrolled systemic infection requiring anti-infective treatment;
- •Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
- •Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
- •Pregnant or lactating women;
- •Those who were considered unsuitable for inclusion by the researchers.
研究组 & 干预措施
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
干预措施: nab-paclitaxel combined with carboplatin (Drug)
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)
干预措施: nab-paclitaxel combined with carboplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 20 months
Disease progression as first failure
次要结局
- Survival(3 years, 5 years)
- Objective Remission Rate(12 months)
- Adverse events(3 years, 5 years)