RecruitingPhase 3NCT05236946

Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT

Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial


Sponsor

Tata Memorial Hospital

Enrollment

190 participants

Start Date

Nov 10, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two approaches for patients with lung cancer (NSCLC) that has spread to the brain but is not causing symptoms: immediate radiation to the brain versus watchful waiting (observation) while taking targeted pills. Researchers want to know if delaying radiation is just as safe. **You may be eligible if...** - You have been diagnosed with NSCLC that has a specific gene mutation (EGFR or ALK) - You have brain metastases confirmed on imaging that are not causing symptoms - You are in reasonably good health (ECOG performance status 0–2) - You are willing to follow-up on the study schedule **You may NOT be eligible if...** - You have only cancer cells in the fluid around the brain (no actual brain lesion) - Your cancer has spread to the brainstem - You have already had radiation to the brain - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic radiosurgery/whole brain radiotherapy

SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases

DRUGTyrosine kinase inhibitor

TKI


Locations(1)

Tata Memorial Hospital

Mumbai, Maharashtra, India

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NCT05236946