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

NCT ID: NCT00980213

Last Updated: 2014-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sunitinib

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

sunitinib

Intervention Type DRUG

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

Interventions

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sunitinib

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Pirkko-Liisa Kellokumpu-Lehtinen

OTHER

Sponsor Role lead

Responsible Party

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Pirkko-Liisa Kellokumpu-Lehtinen

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Oulu Univeristy Hospital

Oulu, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Vaasa Central Hosptital

Vaasa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R09045

Identifier Type: -

Identifier Source: org_study_id

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