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

ConditionsAsymptomatic Brain MetastasesDriver Mutation Positive Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTata Memorial Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic radiosurgery/whole brain radiotherapy

    Radiation

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

  • Tyrosine kinase inhibitor

    Drug

    TKI

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Upfront Cranial RadiotherapyActive comparator 2 interventions
Group B: Observation (Delayed Cranial Radiotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intracranial progression free survival at 24 months

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

Time frame
2 year

Secondary outcomes

1

Overall Survival

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.

Time frame
Upto 5-year
2

Progression free survival

Progression free survival will be defined from the date of randomization to the date of progression or the date of death whichever is earlier.

Time frame
upto 2 year
3

Neurocognition toxicity

Neuro-cognition assessment will be done using HVLT-R (Total Recall) at baseline and at 3, 6 and 12 months for assessable patients

Time frame
Upto 12 months
4

Toxicity using CTC v5.1

Toxicity assessment will be defined as per the common terminology criteria version 5.0 at baseline and at subsequent follow up till 2 years

Time frame
Upto 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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