Study on Adding Whole Brain Radiotherapy with Memory Protection to Targeted Brain Radiation for Cancer Spread to the Brain

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04588246

Provider View

This clinical trial is exploring whether adding whole brain radiotherapy that avoids the memory center, along with a medication called memantine, to targeted brain radiation can help control cancer that has spread to the brain and returned after previous treatment.

Patient Parameters

Program Overview

This study is testing if adding whole brain radiotherapy that avoids the hippocampus, a part of the brain important for memory, along with the drug memantine, to targeted radiation therapy can help manage cancer that has spread to the brain and come back after earlier treatment. The goal is to see if this approach can shrink or stabilize the cancer while minimizing effects on memory and thinking.

Description

The main goal of this study is to find out if combining whole brain radiotherapy that avoids the hippocampus with targeted radiation therapy can extend the time before neurological issues arise in patients whose cancer has spread to the brain and returned after previous treatment.

Secondary goals include assessing if this combination can improve overall survival, delay further cancer progression in the brain, and improve cognitive function compared to targeted radiation therapy alone. The study will also look at the side effects and the number of additional treatments needed after the initial therapy.

Participants will be randomly assigned to one of two groups. One group will receive whole brain radiotherapy with hippocampal avoidance and memantine, along with targeted radiation therapy. The other group will receive only targeted radiation therapy. After treatment, participants will have follow-up visits every 2-3 months for at least a year.

Eligibility Criteria

Inclusion Criteria

  • Cancer has spread to the brain and returned at least 8 weeks after initial targeted radiation therapy.
  • New brain tumors must be 3 cm or smaller and total less than 30 mL in volume.
  • Tumors must be diagnosed using specific MRI techniques.
  • Must have at least 4 new brain tumors per year since initial treatment.
  • Must provide informed consent.
  • Diagnosed with certain types of cancer, such as lung, melanoma, breast, kidney, or gastrointestinal cancer, within the last 10 years.
  • Must have a performance status score of 70 or higher, indicating the ability to care for oneself.
  • Must have adequate kidney function and normal blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Previous whole brain radiation or preventive brain radiation.
  • Cancer that has returned in the same area previously treated.
  • Brain tumors from certain types of cancer, like germ cell tumors or lymphoma.
  • Cancer spread to the brain's lining.
  • Planned chemotherapy on the same day as radiation therapy.
  • Certain brain conditions or inability to undergo MRI.
  • Allergies or contraindications to memantine.
  • Severe health conditions, such as recent heart attack or severe liver disease.
  • HIV positive with low CD4 count, unless well-controlled with treatment.
  • Pregnant or breastfeeding women, or those not using effective contraception.

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