Clinical trial NCT00980213: Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Renal Cell Carcinoma
Keywords: renal cell cancer
sunitinib
costs
quality of life
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Oulu University Hospital
First posted: 2009-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced renal cell cancer patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incremental cost per incremental time to treatment failure (TTF) in first-line treatment
timeFrame: 1 month
Secondary outcomes:
measure: Health related quality of life (HRQoL)
timeFrame: 1 month
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu Univeristy Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hosptital
Study officials:
References: