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Brain MetastasesPhase 2NCT05045950

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique

A Phase 2 study testing Memantine -Twice Daily or Extended Release and WBRT utilizing the PRDR technique in people with Brain Metastases, run by Medical College of Wisconsin at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
Memantine -Twice Daily or Extended Release and WBRT utilizing the PRDR technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesUnited States
Study dates
17 Nov 2021to May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at diagnosis of brain metastases.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of <2.
  • 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.
  • Patients who have undergone prior systemic therapy are eligible.
  • Life expectancy from extracranial disease greater than six months.
  • Patients with measurable brain metastasis.
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  • 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
  • If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.
  • Creatinine clearance is ≥ 30 mL/min.
  • Start of PRDR WBRT within two weeks following registration.
  • Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).
  • Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.
  • Willing and able to give consent and to comply with treatment and follow-up schedule.

Who cannot join

  • Metastases from hematological malignancy, or central nervous system malignancy.
  • Patients whose malignancy is being treated with curative intent.
  • Leptomeningeal metastases.
  • Contraindication to MRI imaging with contrast.
  • Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.
  • Stage IV-V chronic kidney disease or end-stage renal disease.
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  • Participants with a maximum tumor diameter exceeding 5 cm (if not resected).
  • Prior cranial whole brain radiation therapy.
  • Past medical history of dementia which is thought to be unrelated to the brain metastases.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States2 sites, 2 recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Lindsay Puckett, MD, 414-805-4400, lpuckett@mcw.edu

    Recruiting

  • Clement J. Zablocki Veterans Affairs Medical Center

    Milwaukee, Wisconsin, 53295

    Amber Bishop, MS, MA, 414-384-2000 ext. 42593, amber.bishop@va.gov

    Lindsay Puckett, MD

    Recruiting

Other trials in United States

About this study

Official title: Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases

Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.

Read the detailed description

This is a phase II, single-arm, multi-center study assessing the feasibility and tolerance of WBRT using upfront PRDR in the treatment of solid tumor brain metastases. This study will also examine the impact of substituting PRDR for standard whole-brain radiation therapy in the upfront treatment of brain metastases on neurocognitive decline as compared to historical controls. Additionally, clinical patient outcomes associated with radiation treatment of brain metastases will be collected. Using a group sequential design with one interim analysis to stop for futility, the investigators will recruit and enroll 53 adult patients (≥18 years) undergoing upfront treatment of brain metastases to determine feasibility and a preliminary analysis after the first 27 enrolled patients.

In order to be eligible for this study, patients must have a biopsy-proven solid malignancy with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patient who are confirmed to meet all eligibility criteria will be registered to the study and start PRDR WBRT within two weeks postregistration. Patients will receive PRDR WBRT as a dose of 30Gy in 10 fractions and start memantine orally two days prior to (or one day prior to) but no later than the fourth PRDR WBRT treatment session.

Being tested
Memantine -Twice Daily or Extended Release, WBRT utilizing the PRDR technique
Keywords
whole-brain radiation therapy, upfront pulsed reduced dose-rate
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine -Twice Daily or Extended ReleaseDrug

    Also called Namenda

    Both extended release memantine and twice daily memantine dosing will be allowed.

    Twice daily dosing:

    The target dose for memantine is 20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg each week to a target of 10 mg twice daily (i.e., 5 mg a day on week 1, then 5 mg twice daily (BID) on week 2, then 10 mg in AM plus 5 mg in PM on week 3, followed by 10 mg in AM plus 10 mg in PM by week 4).

    Extended Release Memantine:

    The target dose for extended release memantine is 28 mg. Dose will be escalated by 7 mg per week to a target of 28 mg daily (i.e., 7 mg a day on week 1, then 14 mg a day on week 2, then 21 mg a day on week 3, followed by 28 mg a day by week 4).

  • WBRT utilizing the PRDR techniqueRadiation

    The total dose of 3000 cGy (30 Gy) will be divided 10 fractions of 300 cGy (3 Gy); each fraction will be delivered as a series of 20 cGy (0.2Gy) pulses separated by 3 min time intervals. 20 cGy / 3 min = 6.67 cGy/min (or 0.0667 Gy/min). Total time is determined by the fractionated series and time intervals, meaning 300cGy/20cGy = 15 division x 3 minutes = 45 minutes. Including time to set up, approximate total time per treatment session will be 60 minutes.

Study groups in NCT05045950
Study groupRoleWhat they receive
WBRT-PRDR plus memantine.ExperimentalStudy patients will receive WBRT-PRDR within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique. Memantine should ideally start two days (or one day) prior to WBRT PRDR and must start no later than the fourth WBRT PRDR treatment and will continue for a maximum of 24 weeks (≈six months). Memantine will be administered as per standard institutional guidelines.
Receives: Drug: Memantine -Twice Daily or Extended Release; Radiation: WBRT utilizing the PRDR technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful completion of PRDR WBRT treatment

    The number of subjects successfully completing PRDR WBRT treatment within five days of intended treatment completion.

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start17 Nov 2021
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05045950
Sponsor's protocol ID
PRO00041354
Status last verified
Jul 2026
First submitted
7 Sep 2021
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine -Twice Daily or Extended Release and WBRT utilizing the PRDR technique in people with Brain Metastases, run by Medical College of Wisconsin at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful completion of PRDR WBRT treatment (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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