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

P

Pirkko-Liisa Kellokumpu-Lehtinen

Status

Completed

Conditions

Neoplasms
Renal Cell Carcinoma

Treatments

Drug: sunitinib

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

sunitinib
Description:
advanced renal cell cancer patients treated with sunitinib as first-line therapy
Treatment:
Drug: sunitinib

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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