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Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00980213
Enrollment
80
Registered
2009-09-21
Start date
2009-09-30
Completion date
2013-12-31
Last updated
2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Renal Cell Carcinoma

Keywords

renal cell cancer, sunitinib, costs, quality of life

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.

Interventions

DRUGsunitinib

sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months

Sponsors

University of Turku
CollaboratorOTHER
Oulu University Hospital
CollaboratorOTHER
Pirkko-Liisa Kellokumpu-Lehtinen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Clinically indicated first-line sunitinib treatment for advanced RCC. * Informed consent obtained.

Exclusion criteria

* Unable to complete HRQoL forms. * Not consenting to collecting register data.

Design outcomes

Primary

MeasureTime frame
Incremental cost per incremental time to treatment failure (TTF) in first-line treatment1 month

Secondary

MeasureTime frame
Health related quality of life (HRQoL)1 month

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026