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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980213
• Other study ID #: R09045
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: February 5, 2014
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Neoplasms
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu Univeristy Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Finland	Vaasa Central Hosptital	Vaasa

Sponsors (3)

Lead Sponsor	Collaborator
Pirkko-Liisa Kellokumpu-Lehtinen	Oulu University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental cost per incremental time to treatment failure (TTF) in first-line treatment		1 month	No
Secondary	Health related quality of life (HRQoL)		1 month	No