Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
ID: NCT05236946
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
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.
SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases
TKI
Treatment Arms Description
Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases
Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases
- 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
- 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
Primary Outcome Measures
- Intracranial progression free survival at 24 months — Time Frame: 2 year
Intracranial progression free survival will be defined as the time from the date of randomization until the date of intracranial progression is documented. Death without intracranial progression will be considered as a competing event. Intracranial response will be graded as per the Response Assessment in Neuro-Oncology (RANO) guidelines for brain metastases
View Secondary Outcome Measures (5)
- Overall Survival — Time Frame: Upto 5-year
Overall survival will be defined as the time from randomization until the date of death from any cause in the presence or absence of recurrence.
- Progression free survival — Time Frame: upto 2 year
Progression free survival will be defined from the date of randomization to the date of progression or the date of death whichever is earlier.
- Neurocognition toxicity — Time Frame: Upto 12 months
Neuro-cognition assessment will be done using HVLT-R (Total Recall) at baseline and at 3, 6 and 12 months for assessable patients
- Toxicity using CTC v5.1 — Time Frame: Upto 2 years
Toxicity assessment will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years
- Local Control — Time Frame: Upto 2 years
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial