Status:
COMPLETED
Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib
Lead Sponsor:
Radboud University Medical Center
Conditions:
Metastatic Renal Cell Cancer
GIST
Eligibility:
All Genders
18+ years
Brief Summary
Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a tumor of the intestines) may be eligible for treatment with one of the following drugs: sunitinib (Sutent ®) or...
Detailed Description
In this study we will focus on subjective and objective cognitive dysfunctioning in patients with metastatic cancer, treated with sunitinib or sorafenib. In our own clinical practice a substantial par...
Eligibility Criteria
Inclusion
- Patients:
- patients with metastatic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks
- Karnofsky score \> 70%
- age \> 18 year.
- written informed consent for study
- Patient controls selection
- patients with metastatic renal cell cancer or GIST who aren't treated yet (only interferon alfa or interleukine 2 treatment is allowed when \> 12 months ago.
- Karnofsky score \> 70%
- age \> 18 year.
- written informed consent for study
Exclusion
- Patients:
- contra-indications for treatment with Sunitinib or Sorafenib
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- Stroke/TIA (transient ischaemic attack)
- Patient controls section:
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- stroke/TIA (transient ischaemic attack)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01246843
Start Date
July 1 2009
End Date
April 1 2011
Last Update
November 2 2011
Active Locations (1)
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1
University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands, 6500 HB