Status:
RECRUITING
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Asymptomatic Brain Metastases
Driver Mutation Positive Non-small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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 stan...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients with ECOG performance status of 0-2
- Patients with pathologically proven diagnosis of NSCLC
- Patients with positive oncogene mutation status (EGFR/ALK)
- Patients with radiologically confirmed parenchymal brain metastases
- Patients with asymptomatic Synchronous or Metachronous brain metastases
- Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule
Exclusion
- Patients with CSF dissemination only without any parenchymal brain metastases
- Patients with brain metastases in the brain stem
- Patients with prior history of radiation therapy to the brain
- Patient not suitable for TKI therapy as per the medical oncologist
- Pregnant or lactating females
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05236946
Start Date
November 10 2020
End Date
December 1 2026
Last Update
September 10 2025
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012