Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05045950

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

Led by Medical College of Wisconsin · Updated on 2026-05-01

53

Participants Needed

2

Research Sites

388 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at diagnosis of brain metastases
  • Eastern Cooperative Oncology Group (ECOG) Performance Score less than 2
  • Biopsy-proven solid malignancy with brain metastases confirmed by imaging or pathology
  • Prior systemic therapy allowed
  • Life expectancy greater than six months from extracranial disease
  • Presence of measurable brain metastasis
  • Prior brain metastasis treatments allowed if completed at least 7 days (stereotactic radiosurgery) or 14 days (surgical resection) before enrollment
  • At least one week post-open biopsy if performed
  • Creatinine clearance of 30 mL/min or higher
  • Start PRDR WBRT within two weeks after registration
  • Ability to complete neurocognitive function tests in English
  • Previous or other controlled malignancies not affecting performance or life expectancy
  • Willingness and ability to give consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Metastases from blood cancers or primary central nervous system malignancies
  • Malignancy currently treated with curative intent
  • Presence of leptomeningeal metastases
  • Contraindications to MRI with contrast
  • Contraindications to memantine or concurrent use of NMDA antagonists
  • Stage IV-V chronic kidney disease or end-stage renal disease
  • Tumor larger than 5 cm if not surgically removed
  • Prior whole-brain radiation therapy
  • History of dementia unrelated to brain metastases
  • Women of childbearing potential who are pregnant or unwilling to use contraception during treatment
  • Serious medical or psychiatric illnesses preventing consent or study completion
  • Non-native English speakers due to potential impact on cognitive testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

2

Clement J. Zablocki Veterans Affairs Medical Center

Milwaukee, Wisconsin, United States, 53295

Actively Recruiting

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Research Team

M

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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