Study on Normal Tissue Sparing Whole Brain Radiation Therapy for Brain Metastases

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05013892

Provider View

This clinical trial is exploring a new type of radiation therapy called normal tissue sparing whole brain radiation therapy (NTS-WBRT) to see if it can improve quality of life and reduce symptoms for patients with brain metastases. Participants will also receive a standard care drug called Memantine.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new radiation therapy called NTS-WBRT, which targets brain metastases while minimizing exposure to healthy brain tissue. The study will involve screening for eligibility, receiving the treatment, and attending follow-up visits. Approximately 41 people are expected to participate in this research.

Description

This Phase 2 trial is designed to evaluate how safe and effective NTS-WBRT is for treating brain metastases. NTS-WBRT is a specialized form of radiation therapy that aims to protect healthy brain tissue from unnecessary radiation. Participants will undergo a series of procedures, including initial screening to determine eligibility, receiving the study treatment, and attending follow-up visits to monitor their progress. The study aims to improve the quality of life and reduce symptoms for patients with brain metastases. About 41 participants will be involved in this research.

Eligibility Criteria

Inclusion Criteria

  • Have a solid tumor diagnosis with brain metastases that require whole brain radiation therapy.
  • Be 18 years or older.
  • Have a Karnofsky Performance Status score of 70 or higher, indicating the ability to care for oneself.
  • Previous stereotactic radiosurgery (SRS) is allowed if the doctor agrees.
  • Previous brain surgery is allowed if the doctor agrees, but radiation therapy should start at least 2 weeks after surgery.
  • Previous partial brain radiation is allowed if less than 50% of the brain was treated and the doctor agrees.
  • Expected to live more than 6 months.
  • Able to understand and sign a consent form.
  • Fluent in English and able to complete questionnaires and cognitive tests.
  • Able to have an MRI with gadolinium.
  • Able to attend follow-up visits for up to 2 years after treatment.
  • Any other cancer treatments are allowed if the doctor agrees.
  • Negative pregnancy test for women who can become pregnant.

Exclusion Criteria

  • Have leptomeningeal disease, which is cancer spread to the membranes covering the brain and spinal cord.
  • Have had whole brain radiation therapy before.
  • Currently using or have used memantine or similar drugs.
  • Allergic to contrast used in imaging or unable to have an MRI.
  • Have uncontrolled illnesses that affect cognitive function, such as severe heart failure, unstable chest pain, previous stroke, uncontrolled epilepsy, or psychiatric conditions that would interfere with the study.
  • Pregnant or not willing to use contraception during radiation therapy.
  • Participating in another study involving experimental systemic therapy.

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