Ignite Creation Date:
2024-05-05 @ 9:54 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00980213
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2009-09-18
Brief Title:
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
Sponsor:
Pirkko-Liisa Kellokumpu-Lehtinen
Organization:
Tampere University Hospital
Study Overview
Official Title:
Evaluation of the Cost and Effectiveness in the First-line Treatment of Advanced Renal Cell Cancer With Sunitinib Compared to Interferon-alfa in Finland
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient receiving sunitinib according the clinicians 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None