NeoplasmsNCT00980213
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland
An observational study of Neoplasms and Renal Cell Carcinoma, run by Pirkko-Liisa Kellokumpu-Lehtinen at 5 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neoplasms, Renal Cell Carcinoma
- What is being tested?
- sunitinib
- How many people
- 80 participants
- Where
- 5 sitesFinland
- Study dates
- Sep 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced renal cell cancer patients
Who may be able to join
- Clinically indicated first-line sunitinib treatment for advanced RCC.
- Informed consent obtained.
Who cannot join
- Unable to complete HRQoL forms.
- Not consenting to collecting register data.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Kuopio University Hospital
Kuopio
Oulu Univeristy Hospital
Oulu
Tampere University Hospital
Tampere, Fi-33521
Turku University Hospital
Turku, Fi-20520
Vaasa Central Hosptital
Vaasa
About this study
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.
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.
Read more
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.
- Conditions
- Neoplasms, Renal Cell Carcinoma
- Being tested
- sunitinib
- Keywords
- renal cell cancer, sunitinib, costs, quality of life
- Medical subject headings
- Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinibDrug
sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months
| Study group | Role | What they receive |
|---|---|---|
| sunitinib | advanced renal cell cancer patients treated with sunitinib as first-line therapy Receives: Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost per incremental time to treatment failure (TTF) in first-line treatment
Measured: 1 month
Secondary outcomes (1)
Health related quality of life (HRQoL)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirkko-Liisa Kellokumpu-Lehtinen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Oulu University Hospital
- Responsible party
- Sponsor-investigator, Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980213
- Sponsor's protocol ID
- R09045
- Status last verified
- Feb 2014
- First submitted
- 18 Sep 2009
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00980213
- Acronym / sponsor ID
- R09045
- Conditions
- Neoplasms, Renal Cell Carcinoma
- Keywords
- renal cell cancer, sunitinib, costs, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pirkko-Liisa Kellokumpu-LehtinenUniversity, hospital or other
- Collaborators
- University of Turku, Oulu University Hospital
- Study start
- Sep 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib | – | Drug: sunitinibadvanced renal cell cancer patients treated with sunitinib as first-line therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced renal cell cancer patients
Key inclusion criteria (2 listed)
- Clinically indicated first-line sunitinib treatment for advanced RCC.
- Informed consent obtained.
Key exclusion criteria (2 listed)
- Unable to complete HRQoL forms.
- Not consenting to collecting register data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinibsunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months | Drug | sunitinib |
Primary outcome
Incremental cost per incremental time to treatment failure (TTF) in first-line treatment
Time frame: 1 month
1 secondary outcome
Health related quality of life (HRQoL)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Renal Cell Carcinoma, run by Pirkko-Liisa Kellokumpu-Lehtinen at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost per incremental time to treatment failure (TTF) in first-line treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.