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Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Sponsor: Tata Memorial Hospital
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.
Official title: Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2020-11-10
Completion Date
2026-12
Last Updated
2025-09-10
Healthy Volunteers
No
Interventions
Stereotactic radiosurgery/whole brain radiotherapy
SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases
Tyrosine kinase inhibitor
TKI
Locations (1)
Tata Memorial Hospital
Mumbai, Maharashtra, India