Metastatic Renal Cell CancerNCT01246843
Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib
An observational study of Metastatic Renal Cell Cancer and GIST, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Cancer, GIST
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mRCC are asked by their own physician.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Nijmegen
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib
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 sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators knowledge on the effects and side effects of these two medicines, in the University Medical Center St. Radboud lot of research is done. This study is a part of that.
Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less able to concentrate, that their memory is not working properly or that they are less able to imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In how many of the patients this occurs, how severe the symptoms are and how it is caused, is still unknown.
Read more
The goal of this research is to examine how memory, concentration and knowledge processing works in patients using sorafenib or sunitinib. With the research the investigators hope to get answers to the following questions:
- How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib?
- What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- What could be the cause of the problems that patients experience from memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?
Read the 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 part of our patients that are treated with targeted therapies directed against VEGF, mention that they have problems with concentrating and that their memory function is decreased. Relatives sometimes point out that the behaviour of the patient is slightly different than before starting the VEGF (Vascular Endothelial Growth Factor) inhibition. Pre-clinical studies show that VEGF influences growth and recovery of neurons.
- Conditions
- Metastatic Renal Cell Cancer, GIST
- Keywords
- sunitinib, sorafenib, cognitive functioning
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metastatic Renal Cell Carcinoma without treatment | patients with metastasized RCC who did not receive treatment | |
| mRCC with treatment | patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.M.L. van Herpen, Md PhD, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246843
- Sponsor's protocol ID
- UMCNONCO200904
- Status last verified
- Oct 2011
- First submitted
- 22 Nov 2010
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulder SF, Bertens D, Desar IM, Vissers KC, Mulders PF, Punt CJ, van Spronsen DJ, Langenhuijsen JF, Kessels RP, van Herpen CM. Impairment of cognitive functioning during Sunitinib or Sorafenib treatment in cancer patients: a cross sectional study. BMC Cancer. 2014 Mar 24;14:219. doi: 10.1186/1471-2407-14-219.
PubMed 24661373
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib
- ClinicalTrials.gov ID
- NCT01246843
- Acronym / sponsor ID
- UMCNONCO200904
- Conditions
- Metastatic Renal Cell Cancer, GIST
- Keywords
- sunitinib, sorafenib, cognitive functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Nov 2010 (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.
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 sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators knowledge on the effects and side effects of these two medicines, in the University Medical Center St. Radboud lot of research is done. This study is a part of that.
Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less able to concentrate, that their memory is not working properly or that they are less able to imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In how many of the patients this occurs, how severe the symptoms are and how it is caused, is still unknown.
The goal of this research is to examine how memory, concentration and knowledge processing works in patients using sorafenib or sunitinib. With the research the investigators hope to get answers to the following questions:
- How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib?
- What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- What could be the cause of the problems that patients experience from memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?
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 part of our patients that are treated with targeted therapies directed against VEGF, mention that they have problems with concentrating and that their memory function is decreased. Relatives sometimes point out that the behaviour of the patient is slightly different than before starting the VEGF (Vascular Endothelial Growth Factor) inhibition. Pre-clinical studies show that VEGF influences growth and recovery of neurons.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metastatic Renal Cell Carcinoma without treatment | – | –patients with metastasized RCC who did not receive treatment |
| mRCC with treatment | – | –patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mRCC are asked by their own physician.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Nov 2011.
- Derived from this study: PubMed 24661373Mulder SF, Bertens D, Desar IM, Vissers KC, Mulders PF, Punt CJ, van Spronsen DJ, Langenhuijsen JF, Kessels RP, van Herpen CM. Impairment of cognitive functioning during Sunitinib or Sorafenib treatment in cancer patients: a cross sectional study. BMC Cancer. 2014 Mar 24;14:219. doi: 10.1186/1471-2407-14-219.
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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.
C.M.L. van Herpen, Md PhD principal investigator
University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Cancer and GIST, run by Radboud University Medical Center at 1 site in Netherlands.
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 10 inclusion and 21 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246843, which also lists 1 linked publication.
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 2 Nov 2011.