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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

Must not have

Prior cranial whole brain radiation therapy

Leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had whole brain radiation therapy before.

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My cancer has spread to the lining of my brain and spinal cord.

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I cannot take memantine or similar medications due to health reasons.

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My cancer has spread from the blood or brain.

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My cancer treatment is aimed at curing the disease.

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My tumor is larger than 5 cm and has not been removed.

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My kidney function is severely reduced or I am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful completion of PRDR WBRT treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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.

0 / 11Eligibility criteria met