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Radiation Therapy

PRDR WBRT for Brain Cancer

Phase 2
Recruiting
Led By Hina Saeed, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at diagnosis of brain metastases
Patients with measurable brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study Summary

This trial is testing a new way to give radiation therapy to the brain. Patients will get radiation therapy every day for 10 days.

Who is the study for?
This trial is for adults over 18 with brain metastases from solid tumors, expected to live more than six months. They must have a good performance status, be able to do neurocognitive tests, and start treatment within two weeks of joining. Prior treatments are okay except whole brain radiation. Pregnant women or those not using contraception, non-English speakers, and patients with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests Whole-brain radiation therapy (WBRT) using a Pulsed Reduced Dose-Rate (PRDR) technique alongside Memantine medication. Patients will receive daily WBRT sessions in ten fractions totaling 30 Gy via the PRDR method to optimize neurocognition in brain tumor treatment.See study design
What are the potential side effects?
Possible side effects include typical radiation-related issues like hair loss, skin irritation at the site of treatment, fatigue, headaches and memory problems. Memantine may cause dizziness, confusion or constipation among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was 18 or older when my brain cancer was diagnosed.
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I have brain metastasis that can be measured.
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I can do most of my daily activities without help.
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I have cancer that has spread to my brain, confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful completion of PRDR WBRT treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: WBRT-PRDR plus memantine.Experimental Treatment2 Interventions
Study 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.

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Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,444 Total Patients Enrolled
Hina Saeed, MDPrincipal InvestigatorMedical College of Wisconsin
Lindsay Puckett, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

WBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05045950 — Phase 2
Brain Tumor Research Study Groups: WBRT-PRDR plus memantine.
Brain Tumor Clinical Trial 2023: WBRT Highlights & Side Effects. Trial Name: NCT05045950 — Phase 2
WBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05045950 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in the research study?

"That is accurate. According to the details posted on clinicaltrials.gov, this research project first appeared on November 17th 2021 and was recently adjusted as of April 5th 2022. The goal is to enlist 53 patients from a single medical location."

Answered by AI

Could you please elucidate the risks posed by WBRT under PRDR procedures?

"Taking all possible factors into consideration, the safety rating of WBRT with PRDR is approximated at a 2. This assessment takes into account that this is only Phase 2 trial and there has yet to be data demonstrating efficacy."

Answered by AI

Is enrollment open for this investigation?

"Indeed. On clinicaltrials.gov, this trial is listed as actively recruiting participants since its inception on November 17th 2021 and last edit on April 5th 2022. The study seeks to enroll 53 patients from a single medical centre."

Answered by AI

Has there been an exploration of whole brain radiation therapy (WBRT) with the utilization of planar radiotherapy dose reduction (PRDR) in any other studies?

"Currently, 25 trials are in progress researching WBRT and its potential efficacy when using the PRDR technique. Of those studies, 11 have now advanced to Phase 3 of clinical trial research. While many West Bend, Wisconsin-based sites are running these experiments, there is a total of 294 locations conducting this inquiry worldwide."

Answered by AI
~2 spots leftby May 2024