An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of participants showing adverse events
研究概览
简要总结
To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age over 18
- •Patients consented to participate
- •Pathologically diagnosed ovarian cancer FIGO stage IC-IVB
- •Patients with an expected survival of 3 months or more
排除标准
- •History of paclitaxel or carboplatin hypersensitivity
- •Inadequate bone marrow function (Neutrophil<1500/mm3, Platelet <100,000/mm3)
- •Pregnancy or breast-feeding state
- •Metachronous or synchronous malignancy
- •Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems
- •Other patients who were judged difficult to be included in this investigation by the investigator in charge
研究组 & 干预措施
Genexol PM
Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
干预措施: Genexl PM (Drug)
结局指标
主要结局
Number of participants showing adverse events
时间窗: From the time of treatment start date through 30 days following cessation of treatment
Number of any adverse event assessed based on CTCAE 4.0
次要结局
- Neurotoxicity(From the time of treatment start date through 30 days following cessation of treatment)
- other toxicity(From the time of treatment start date through 30 days following cessation of treatment)
研究者
Hee Seung Kim
Professor
Seoul National University Hospital