NSCLC
Conditions
Interventions
baseline: physical examination, neurocognitive questionnaires, MRI (when not already performed as standard care), optional: blood/CSF
2 weeks after completion of cranial radiotherapy: physical examin
Sponsors
Maastricht UMC+
PO Box 5800 6202 AZ Maastricht
The Netherlands
Eligibility
Inclusion criteria
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 - Indication for cranial radiotherapy determined by treating physician and radiation oncologist - Age ¡Ý 18 years - Ability to understand neurocognitive testing - Written informed consent
Exclusion criteria
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. - Neurologic/psychiatric illnesses (such as Alzheimer¡¯s disease) - Claustrophobia - Metal implants or other contra-indication for MRI - Inability to lie supine for 30 minutes time (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Increase in neurotoxicity 4 months after completion of cranial radiotherapy compared to baseline data | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase in neurotoxicity 6 months after completion of cranial radiotherapy compared to baseline data. | — |
Contacts
Public ContactLizza Hendriks
Maastricht UMC
Outcome results
None listed