New radiation method aims to shield brain function during cancer treatment
NCT ID NCT05045950
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This phase II trial tests a special way of delivering whole-brain radiation called pulsed reduced dose-rate (PRDR) along with the drug memantine to help protect memory and thinking in people with brain metastases. About 53 adults with solid tumors that have spread to the brain will receive 30 Gy of radiation in 10 sessions using the PRDR technique. The main goal is to see if patients can complete the treatment as planned, with a focus on preserving neurocognitive function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pulsed reduced dose-rate whole-brain radiation therapy and memantine (Namenda)
- What this could lead to
- If successful, this approach could help preserve memory and thinking skills in patients needing whole-brain radiation for brain metastases.
- What could go wrong
- This is a small, early-phase trial with only 53 participants, so results may not apply broadly. The treatment may still cause cognitive decline or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at diagnosis of brain metastases. 2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2. 3. Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. 4. Patients who have undergone prior systemic therapy are eligible. 5. Life expectancy from extracranial disease greater than six months. 6. Patients with measurable brain metastasis. 7. Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS and at least 14 days for surgical resection 8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies. 9. Creatinine clearance is ≥ 30 mL/min. 10. Start of PRDR WBRT within two weeks following registration. 11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English). 12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy. 13. Willing and able to give consent and to comply with treatment and follow-up schedule. Exclusion Criteria: 1. Metastases from hematological malignancy, or central nervous system malignancy. 2. Patients whose malignancy is being treated with curative intent. 3. Leptomeningeal metastases. 4. Contraindication to MRI imaging with contrast. 5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists. 6. Stage IV-V chronic kidney disease or end-stage renal disease. 7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected). 8. Prior cranial whole brain radiation therapy. 9. Past medical history of dementia which is thought to be unrelated to the brain metastases. 10. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy. 11. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and/or follow-up visits. 12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clement J. Zablocki Veterans Affairs Medical Center
RECRUITINGMilwaukee, Wisconsin, 53295, United States
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Froedtert Hospital & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Other studies related to the condition(s) this trial covers.
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- Can a new pill outsmart lung cancer in the brain?