Skip to content
TrialMatch
Sign up
Recruiting Phase 3

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer
Tested
Stereotactic radiosurgery/whole brain radiotherapy, Tyrosine kinase inhibitor
Sponsor
Tata Memorial Hospital

Who can join

Age
18 to 99 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 99 years
  • Study condition: Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer
  • 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 5

  • 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

Where

1 site, 1 recruiting

Tata Memorial Hospital

Mumbai, Maharashtra, India

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.