NCT04609800撤回不适用
CAROLINE: An Observational, Prospective, Multicenter Study, on the Utilization of Cabozantinib in Adult Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) in 2nd Line Treatment Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy Under Real-real Life Clinical Setting in France.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Ipsen
- 主要终点
- Overall survival (OS) rate at 1 year after cabozantinib initiation
研究概览
简要总结
The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 age at the time of cabozantinib initiation
- •Pathologically confirmed diagnosis of Renal Cell Carcinoma (Clear Cell or non-Clear Cell) cancer considered as advanced or metastatic at the time of cabozantinib initiation
- •Intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (France)
- •Initiating cabozantinib as a second line of treatment (Baseline visit must be performed before cabozantinib first intake)
排除标准
- •He/she is already included in an interventional trial with an investigational product at the same time.
结局指标
主要结局
Overall survival (OS) rate at 1 year after cabozantinib initiation
时间窗: up to 12 months
OS is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive if before 1 year.
次要结局
- Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.(Baseline)
- Progression Free Survival (PFS) at 1 year(Day 15, 1 month, 3, 6 and 12 months)
- Best Overall Response (BOR) at 1 year(Day 15, 1 month, 3, 6 and 12 months)
- Pattern of use of cabozantinib(Baseline, day 15, 1 month, 3, 6 and 12 months)
- Quality of life (QoL) change according to Functional Assessment of Cancer Therapy (FKSI-19) questionnaire(Baseline, day 15, 1 month, 3, 6 and 12 months)
- Objective Response Rate (ORR) at 1 year(Day 15, 1 month, 3, 6 and 12 months)
- First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.(Baseline)
- Subsequent systemic treatment for RCC after cabozantinib discontinuation in terms of the description of the nature of the therapy, starting date.(End of Study visit (12 months if the patient didn't discontinue earlier))
- Safety of cabozantinib in the real-world setting(Day 15, 1 month, 3, 6 and 12 months)
- Pain assessment(Baseline, day 15, 1 month, 3, 6 and 12 months)
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