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Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

NCT04804644 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-04

No results posted yet for this study

Summary

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

Conditions

  • Metastatic Lung Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Recurrent Lung Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Memantine Hydrochloride

Given PO

OTHER

Neurocognitive Assessment

Ancillary studies

RADIATION

Stereotactic Radiosurgery

Undergo SRS

OTHER

Survey Administration

Ancillary studies

RADIATION

Whole-Brain Radiotherapy

Undergo HA-WBRT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Vinai Gondi · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2028-07-01
Completion
2030-07-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804644 on ClinicalTrials.gov