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临床试验/NCT00980213
NCT00980213已完成不适用

Evaluation of the Cost and Effectiveness in the First-line Treatment of Advanced Renal Cell Cancer With Sunitinib Compared to Interferon-alfa in Finland.

Pirkko-Liisa Kellokumpu-Lehtinen5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年9月最近更新:
适应症
干预措施

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

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

发起方
Pirkko-Liisa Kellokumpu-Lehtinen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pirkko-Liisa Kellokumpu-Lehtinen

Prof

Tampere University Hospital

研究点 (5)

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