Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 820
- 试验地点
- 38
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer.
Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.
详细描述
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The high mortality rate is due to the late diagnosis of this malignancy that often develops without symptoms, as well as to limited results in treatment of the disease. Patients may respond well initially to chemotherapy, but the vast majority of patients will experience a progression of the disease. The poor long term results in the standard treatment available today for first-line chemotherapy of ovarian cancer make research into new, more beneficial treatment strategies necessary. The proven efficacy of liposomal doxorubicin in second line treatment, where it is the first drug to have shown some significant benefit in terms of survival, and the possibility of easily combining it with full doses and normal use of carboplatin, encourages the testing of the effectiveness of the combination of carboplatin and liposomal doxorubicin in first line treatment.
Patients enrolled into this study will be randomly assigned to one of two treatment groups:
· Standard therapy consisting of 6 cycles of chemotherapy:
- carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND
- paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks
OR
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer
- •Indication for chemotherapy treatment
- •Age 75 years or less
- •Life expectancy of at least 3 months
排除标准
- •Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Performance status (ECOG) > 2
- •Previous chemotherapy treatment
- •Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
- •Leukocytes < 4000/mm3, neutrophils < 2000/mm3, platelets < 100000/mm3
- •Impaired renal function (creatinine > 1.25 times the upper normal limit) or liver function (SGOT or SGPT > 1.25 times the upper normal limit)
- •Present or suspected hemorrhagic syndromes
- •Uncooperative and/or unreliable patients
- •Patient's inability to access the center
- •Refusal of informed consent
研究组 & 干预措施
carboplatin and liposomal doxorubicin
干预措施: liposomal doxorubicin (Drug)
carboplatin and liposomal doxorubicin
干预措施: carboplatin (Drug)
carboplatin and paclitaxel
干预措施: carboplatin (Drug)
carboplatin and paclitaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression free survival
时间窗: at 2 years
次要结局
- quality of life(at baseline and every 3 weeks during treatment)
- overall survival(4 years)
- adverse events(every 3 weeks during chemotherapy)
- objective response rate(at 9 and 18 weeks after starting study therapy)