TKI concurrent with cerebral radiation therapy Dutch: TKI tegelijkertijd met bestraling van de hersene
Recruiting
- Conditions
- neurotoxicity<br /><br />niet-kleincellig longkankerhersenmetastasenbestraling van de hersenenconcurrent treatmentSCLCbrain metastasesgelijktijdige behandelingcranial radiotherapyneurotoxiciteit
- Registration Number
- NL-OMON28884
- Lead Sponsor
- Maastricht UMC+<br>PO Box 5800 6202 AZ Maastricht<br>The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
To be eligible to participate in this study, a patient must meet all of the following criteria:
-Stage IV NSCLC with driver mutation, treated with TKI, development of brain metastases during TKI treatment
Exclusion Criteria
A potential patient who meets any of the following criteria will be excluded from participation in this study:
-Prior radiotherapy to the brain when this precludes new radiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in incidence of acute severe toxicity (per TKI) 2 weeks after completion of cranial radiotherapy, measured with CTCAE v 4.0, compared to baseline data<br><br /><br /><br>Increase in neurotoxicity 4 months after completion of cranial radiotherapy compared to baseline data
- Secondary Outcome Measures
Name Time Method Increase in neurotoxicity 6 months after completion of cranial radiotherapy compared to baseline data.