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| Name | Class |
|---|---|
| University of Turku | OTHER |
| Oulu University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunitinib | advanced renal cell cancer patients treated with sunitinib as first-line therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib | Drug | sunitinib 50 mg, per os, daily for 4 weeks then 2 weeks pause, duration months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost per incremental time to treatment failure (TTF) in first-line treatment | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (HRQoL) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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advanced renal cell cancer patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Finland | ||||
| Oulu Univeristy Hospital |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Oulu |
| Finland |
| Tampere University Hospital | Tampere | Fi-33521 | Finland |
| Turku University Hospital | Turku | Fi-20520 | Finland |
| Vaasa Central Hosptital | Vaasa | Finland |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |