Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic radiosurgery/whole brain radiotherapy, Tyrosine kinase inhibitor.
- Who it may be relevant to
- Registry conditions: Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial
Overview
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.
Interventions
- Radiation Stereotactic radiosurgery/whole brain radiotherapy
SRS/ WBRT for asymptomatic brain metastases depending on the number of brain metastases - Drug Tyrosine kinase inhibitor
TKI
Primary outcome measures
- Intracranial progression free survival at 24 months [Time frame: 2 year]
Secondary outcome measures (5)
- Overall Survival [Time frame: Upto 5-year]
- Progression free survival [Time frame: upto 2 year]
- Neurocognition toxicity [Time frame: Upto 12 months]
- Toxicity using CTC v5.1 [Time frame: Upto 2 years]
- Local Control [Time frame: Upto 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Tata Memorial Hospital — Mumbai
Identifiers
NCT: NCT05236946 · CTRI/2020/08/027279 · IEC/3470