NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 65
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Women aged 18 years or older.
- •Presence of platinum-sensitive relapsed ovarian cancer.
- •Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
- •Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
- •Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.
排除标准
- 未提供
结局指标
主要结局
Progression-Free Survival
时间窗: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Progression Free Survival by Prior Antiangiogenic Treatment
时间窗: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Progression Free Survival by BRCA1/2 Status
时间窗: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Progression Free Survival by Platinum Sensitivity
时间窗: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Overall Survival by Prior Antiangiogenic Treatment(From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019))
- Overall Survival by BRCA1/2 Status(From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019))
- Best Tumor Response(From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019))
- Best Response by Prior Antiangiogenic Treatment(From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019))
- Overall Survival by Platinum Sensitivity(From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019))
- Change From Baseline to Best Post-baseline ECOG Performance Status Score(Through study completion, up to 4.5 years (Jan 2015 to Sept 2019))
- Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment(Through study completion, up to 4.5 years (Jan 2015 to Sept 2019))
- Overall Survival(From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019))