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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980213
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : February 6, 2014
University of Turku
Oulu University Hospital
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital

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
Neoplasms Renal Cell Carcinoma Drug: sunitinib

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 : September 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Incremental cost per incremental time to treatment failure (TTF) in first-line treatment [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Health related quality of life (HRQoL) [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
advanced renal cell cancer patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980213

Kuopio University Hospital
Kuopio, Finland
Oulu Univeristy Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland, Fi-33521
Turku University Hospital
Turku, Finland, Fi-20520
Vaasa Central Hosptital
Vaasa, Finland
Sponsors and Collaborators
Pirkko-Liisa Kellokumpu-Lehtinen
University of Turku
Oulu University Hospital

Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, Prof, Tampere University Hospital Identifier: NCT00980213     History of Changes
Other Study ID Numbers: R09045
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital:
renal cell cancer
quality of life

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors