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New radiation method aims to shield brain function during cancer treatment

NCT ID NCT05045950

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 53 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clement J. Zablocki Veterans Affairs Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53295, United States

  • Froedtert Hospital & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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