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

Launched by TATA MEMORIAL HOSPITAL · Feb 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to treat patients with non-small cell lung cancer (NSCLC) who have certain gene mutations and have small areas of cancer in their brain but are not showing any symptoms. The trial compares two approaches: starting treatment with radiation to the brain right away or waiting to see if treatment is needed later. Researchers want to find out if immediate radiation is more effective than delaying it, especially since newer medications called Tyrosine Kinase Inhibitors (TKIs) can also help treat brain cancer without the side effects that come with radiation.

To participate in this study, you must be at least 18 years old and have a confirmed diagnosis of NSCLC with specific gene mutations (like EGFR or ALK). You should also have small brain tumors that are not causing any symptoms. Participants will be monitored closely throughout the trial, and they’ll need to agree to follow-up appointments. This study is currently recruiting participants, and it may offer insights into how best to manage brain metastases in this patient group without unnecessary treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Patients with ECOG performance status of 0-2
• • 3. Patients with pathologically proven diagnosis of NSCLC
• • 4. Patients with positive oncogene mutation status (EGFR/ALK)
• • 5. Patients with radiologically confirmed parenchymal brain metastases
• • 6. Patients with asymptomatic Synchronous or Metachronous brain metastases
• • 7. Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule
• Exclusion Criteria:
• • 1. Patients with CSF dissemination only without any parenchymal brain metastases
• • 2. Patients with brain metastases in the brain stem
• • 3. Patients with prior history of radiation therapy to the brain
• • 4. Patient not suitable for TKI therapy as per the medical oncologist
• • 5. Pregnant or lactating females