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OpenTrials
Completed

NCT Number: NCT00980213

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sunitinib

Drug

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

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. Health related quality of life (HRQoL)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Pirkko-Liisa Kellokumpu-Lehtinen

Other

Collaborators

  • Oulu University Hospital
  • University of Turku

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2009
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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