Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
- Registration Number
- NCT00980213
- Lead Sponsor
- Pirkko-Liisa Kellokumpu-Lehtinen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Clinically indicated first-line sunitinib treatment for advanced RCC.
- Informed consent obtained.
- Unable to complete HRQoL forms.
- Not consenting to collecting register data.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description sunitinib sunitinib advanced renal cell cancer patients treated with sunitinib as first-line therapy
- Primary Outcome Measures
Name Time Method Incremental cost per incremental time to treatment failure (TTF) in first-line treatment 1 month
- Secondary Outcome Measures
Name Time Method Health related quality of life (HRQoL) 1 month
Trial Locations
- Locations (5)
Kuopio University Hospital
🇫🇮Kuopio, Finland
Oulu Univeristy Hospital
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Turku University Hospital
🇫🇮Turku, Finland
Vaasa Central Hosptital
🇫🇮Vaasa, Finland
Kuopio University Hospital🇫🇮Kuopio, Finland