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

This study has been completed.
Sponsor:
Collaborators:
University of Turku
Oulu University Hospital
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00980213
First received: September 18, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention
Neoplasms
Renal Cell Carcinoma
Drug: sunitinib

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Incremental cost per incremental time to treatment failure (TTF) in first-line treatment [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life (HRQoL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2009
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

advanced renal cell cancer patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980213

Locations
Finland
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
  More Information

No publications provided

Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, Prof, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00980213     History of Changes
Other Study ID Numbers: R09045
Study First Received: September 18, 2009
Last Updated: February 5, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
renal cell cancer
sunitinib
costs
quality of life

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Sunitinib
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014