Image

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

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

Recruiting
18-99 years
All
Phase 3

Powered by AI

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.

Eligibility

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

Study details
    Asymptomatic Brain Metastases
    Driver Mutation Positive Non-small Cell Lung Cancer

NCT05236946

Tata Memorial Hospital

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.