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

Sponsor

Pirkko-Liisa Kellokumpu-Lehtinen (Other)

Overall Status

Completed

CT.gov ID

NCT00980213

Collaborator

University of Turku (Other), Oulu University Hospital (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Renal Cell Carcinoma	Drug: sunitinib

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

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.

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
sunitinib advanced renal cell cancer patients treated with sunitinib as first-line therapy	Drug: sunitinib sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months

Arm

Intervention/Treatment

sunitinib

advanced renal cell cancer patients treated with sunitinib as first-line therapy

Drug: sunitinib

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

Outcome Measures

Primary Outcome Measures

Incremental cost per incremental time to treatment failure (TTF) in first-line treatment [1 month]

Secondary Outcome Measures

Health related quality of life (HRQoL) [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kuopio University Hospital	Kuopio	Finland
2	Oulu Univeristy Hospital	Oulu	Finland
3	Tampere University Hospital	Tampere	Finland	Fi-33521
4	Turku University Hospital	Turku	Finland	Fi-20520
5	Vaasa Central Hosptital	Vaasa	Finland