Safety of TKI concurrent with cranial radiotherapy in NSCLC patients; the SATIN platform trial

Phase 4

Recruiting

• Conditions: non-small cell lung cancer brain metastases; 10006288

• Registration Number: NL-OMON54721
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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 >= 18 years
- Ability to understand neurocognitive testing
- Written informed consent

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives:<br /><br>- To assess whether there is an increase in acute severe toxicity (per TKI<br /><br>cohort) 2 weeks after completion of cranial radiotherapy measured with CTCAE v<br /><br>4.0.<br /><br>- To assess whether there is an increase in neurotoxicity (measured with<br /><br>neurocognitive testing, per TKI cohort) 4 months after completion of cranial<br /><br>radiotherapy compared to the baseline measurement. </p><br>