Advanced or Metastatic Renal Cell Carcinoma, Renal Cancer
Conditions
Keywords
renal cell carcinoma, sunitinib malate
Brief summary
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Detailed description
Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Interventions
DRUGSutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Exclusion criteria
* Hypersensitivity to sunitinib malate or to any of the excipients * Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Dose modifications | 36 months |
| Incidence of new diagnosed hypertension | 36 months |
| Incidence of new diagnosed hypothyroidism | 36 months |
| Safety of sunitinib malate in real-life setting | 36 months |
| Efficacy of sunitinib malate in real-life setting | 36 months |
Countries
Slovakia
Outcome results
None listed