Stereotactic radiosurgery/whole brain radiotherapy: SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases
Tyrosine kinase inhibitor: TKI
Study summary
Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years
2. Patients with ECOG performance status of 0-2
3. Patients with pathologically proven diagnosis of NSCLC
4. Patients with positive oncogene mutation status (EGFR/ALK)
5. Patients with radiologically confirmed parenchymal brain metastases
6. Patients with asymptomatic Synchronous or Metachronous brain metastases
7. Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule
Exclusion Criteria:
1. Patients with CSF dissemination only without any parenchymal brain metastases
2. Patients with brain metastases in the brain stem
3. Patients with prior history of radiation therapy to the brain
4. Patient not suitable for TKI therapy as per the medical oncologist
5. Pregnant or lactating females
Primary outcome measure(s)
Intracranial progression free survival at 24 months — 2 year Intracranial progression free survival will be defined as the time from the date of randomization until the date of intracranial progression is documented. Death without intracranial progression will be considered as a competing event. Intracranial response will be graded as per the Response Assessment in Neuro-Oncology (RANO) guidelines for brain metastases
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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