Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Incremental cost per incremental time to treatment failure (TTF) in first-line treatment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Health related quality of life (HRQoL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
advanced renal cell cancer patients treated with sunitinib as first-line therapy
sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months
|Contact: Pirkko-Liisa Kellokumpu-Lehtinen, M.D:, Ph.dD.||+358505951103||Pirkko-Liisa.Kellokumpu-Lehtinen@pshp.fi|
|Kuopio University Hospital||Recruiting|
|Contact: Vesa Kataja, M.D.Ph.D Vesa.Kataja@kuh.fi|
|Oulu Univeristy Hospital||Recruiting|
|Contact: Taina Turpeenniemi-Hujanen, M.D., Ph.D. +358407555302|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, Fi-33521|
|Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, M.D., Ph.D. +358505951103 Pirkko-Liisa.Kellokumpu-Lehtinen@pshp.fi|
|Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, M.D., Ph.D.|
|Turku University Hospital||Recruiting|
|Turku, Finland, Fi-20520|
|Contact: Seppo Pyrhönen, M.D., Ph.D. +358505011145 Seppo.Pyrhonen@tyks.fi|
|Vaasa Central Hosptital||Recruiting|
|Contact: Antti Jekunen, M.D., Ph.D. Antti.Jekunen@vks.fi|