Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery

Summary

This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on neurocognitive function (including thinking and memory). Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine may be effective in reducing the size of the cancer or keeping the cancer the same size when it has spread to the brain and/or come back in other areas of the brain compared to stereotactic radiosurgery.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Lung Small Cell Carcinoma
• Metastatic Malignant Breast Neoplasm
• Metastatic Malignant Digestive System Neoplasm
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Renal Cell Carcinoma
• Recurrent Brain Neoplasm
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Memantine

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Radiosurgery

Undergo SRS/fSRS

RADIATION

Whole-Brain Radiotherapy

Undergo HA-WBRT

Sponsors & Collaborators

• NRG Oncology

  lead OTHER

• National Cancer Institute (NCI)

  collaborator NIH

Principal Investigators

• Vinai Gondi · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-05

Primary Completion

2024-08-06

Completion

2024-08-06

Countries

• United States
• Canada
• Hong Kong

Study Locations