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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Memantine Hydrochloride — DRUG
  Given PO
• Neurocognitive Assessment — OTHER
  Ancillary studies
• Stereotactic Radiosurgery — RADIATION
  Undergo SRS
• Survey Administration — OTHER
  Ancillary studies
• Whole-Brain Radiotherapy — RADIATION
  Undergo HA-WBRT

Study Details

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.

Key Dates

Start date

Jun 8, 2021

Status verified

Apr 2026

Primary completion

Jul 1, 2028

Completion

Jul 1, 2030

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (SRS)
  Patients undergo SRS over 1 day (in some cases several days). Patients undergo blood sample collection and MRI throughout the study.
• Active Comparator: Arm II (HA-WBRT, memantine)
  Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the study.

Primary Outcome Measure

Time to neurocognitive failure [ Time Frame: Up to 1 year ]

Locations (223)

Find similar trials in Phoenix, AZ

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