Evaluation of the Cost and Effectiveness in the First-line Treatment of Advanced Renal Cell Cancer With Sunitinib Compared to Interferon-alfa in Finland.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Incremental cost per incremental time to treatment failure (TTF) in first-line treatment
研究概览
简要总结
Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded.
The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment.
Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population.
At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically indicated first-line sunitinib treatment for advanced RCC.
- •Informed consent obtained.
排除标准
- •Unable to complete HRQoL forms.
- •Not consenting to collecting register data.
研究组 & 干预措施
sunitinib
advanced renal cell cancer patients treated with sunitinib as first-line therapy
干预措施: sunitinib (Drug)
结局指标
主要结局
Incremental cost per incremental time to treatment failure (TTF) in first-line treatment
时间窗: 1 month
次要结局
- Health related quality of life (HRQoL)(1 month)
研究者
Pirkko-Liisa Kellokumpu-Lehtinen
Prof
Tampere University Hospital
