A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
研究概览
简要总结
The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who aged 18 years or older
- •Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- •Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
排除标准
- •Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
- •Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
- •Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
研究组 & 干预措施
Genexol®-PM plus Carboplatin
干预措施: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC (Drug)
Genexol® plus Carboplatin
干预措施: Genexol® 175mg/m2 plus Carboplatin 5 AUC (Drug)
结局指标
主要结局
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
时间窗: up to 6 cycles
Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse.
次要结局
- Overall Survival(up to 3 years)
- Progression Free Survival(up to 3 years)
- Time to Progression(up to 3 years)