Study Comparing High-Dose Radiation to Specific Brain Cancer Sites Versus Whole Brain Radiation Avoiding Memory Areas to Prevent Memory and Thinking Loss

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04804644

Provider View

This clinical trial is exploring whether targeting high-dose radiation only to brain cancer sites is better at preserving memory and thinking abilities compared to whole brain radiation that avoids the memory area, in patients with small cell lung cancer that has spread to the brain.

Patient Parameters

Program Overview

This study is comparing two types of radiation treatments for small cell lung cancer that has spread to the brain. One treatment uses a precise method called stereotactic radiosurgery (SRS) to deliver a high dose of radiation directly to the tumor, potentially causing less harm to normal brain tissue. The other treatment involves whole brain radiation therapy (WBRT) that avoids the hippocampus, a part of the brain important for memory, and is combined with a drug called memantine to help reduce side effects related to thinking and memory. The study aims to find out which method better prevents memory and thinking problems.

Description

Primary Objective:

  • To determine if stereotactic radiosurgery (SRS) is better than whole brain radiation therapy with hippocampal avoidance (HA-WBRT) plus memantine in preventing memory and thinking problems in patients with brain metastases from small cell lung cancer (SCLC).

Secondary Objectives:

  • To see if SRS better preserves memory and thinking abilities as measured by specific tests.
  • To assess patients' perceived difficulties in thinking and memory after SRS compared to HA-WBRT plus memantine.
  • To evaluate symptom burden using a specific symptom inventory after SRS compared to HA-WBRT plus memantine.
  • To compare the progression of brain disease and overall survival between the two treatments.
  • To compare the number of additional procedures needed to manage returning brain disease.
  • To compare side effects and the risk of brain tissue damage between the two treatments.

Exploratory Objectives:

  • To compare the recurrence of brain cancer and the cost of treatments between the two methods.
  • To evaluate the time delay to additional whole brain radiation in patients receiving SRS.
  • To assess if delaying chemotherapy in patients receiving HA-WBRT plus memantine affects survival.
  • To evaluate brain imaging markers as predictors of cognitive decline.
  • To collect blood and imaging studies for future research.

Study Design:

  • Participants are randomly assigned to one of two groups.
  • Group 1: Undergoes SRS over one or several days.
  • Group 2: Receives HA-WBRT daily for two weeks and takes memantine for up to 24 weeks.
  • Follow-up visits occur every 2-3 months for the first year, then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with small cell lung cancer within the last 5 years.
  • Have 10 or fewer brain metastases, each 3 cm or smaller, located outside a 5-mm margin around the hippocampus.
  • Brain metastases must be visible on an MRI done within 21 days before joining the study.
  • Age 18 or older.
  • Good overall health with a performance status of 70 or higher.
  • Adequate kidney function.
  • Brain metastases must be asymptomatic and not in critical brain areas if treated with systemic therapy before joining the study.
  • Concurrent immunotherapy with brain radiation is allowed.
  • Negative pregnancy test for women of childbearing potential.
  • Must have completed any prior brain surgery at least 14 days before joining.
  • Must be proficient in English or French Canadian.
  • Must provide informed consent.
  • Must complete specific neurocognitive tests before the second step of registration.

Exclusion Criteria

  • Planned chemotherapy on the same day as radiation treatment.
  • Allergic reaction to memantine.
  • Frequent seizures despite treatment.
  • Definite spread of cancer to the brain's protective layers.
  • History of certain brain diseases like multiple sclerosis.
  • Cannot undergo MRI due to metal implants or allergies.
  • Current use of certain medications like amantadine or ketamine.
  • Significant changes in brain structure affecting the hippocampus.
  • Previous brain radiation treatments.
  • Severe health conditions like recent heart attack or severe infections.

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