Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Recruiting · NCT05236946 · Interventional (participants receive a specific treatment) · Lead sponsor: Tata Memorial Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Stereotactic radiosurgery/whole brain radiotherapyTyrosine kinase inhibitor
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
1 location listed.
- Tata Memorial Hospital - Mumbai, Maharashtra, India