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NTS-WBRT vs. HA-WBRT for Brain Cancer

Phase 2

Recruiting

Led By Helen A Shih, MD, MS, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy

Negative pregnancy test for premenopausal women

Must not have

Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)

Pre-existing or current use of memantine or other NMDA antagonists

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2, 4, 6, 9, 12, 18 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare quality of life and symptom burden of patients receiving NTS-WBRT vs. HA-WBRT, with or without memantine.

Who is the study for?

Adults with brain metastases from solid tumors, who can have an MRI and are expected to live more than 6 months. They should be able to perform daily activities well (Karnofsky score ≥70), understand English, consent in writing, and return for follow-ups for up to 2 years. Pregnant women or those using certain drugs like memantine are excluded.

What is being tested?

The trial compares two radiation therapies: NTS-WBRT which spares normal tissue, and HA-WBRT that avoids the hippocampus area of the brain. Both groups will also receive Memantine. The goal is to see which treatment better maintains quality of life.

What are the potential side effects?

Possible side effects include fatigue, hair loss at treatment sites, skin irritation around the scalp, headaches, nausea, memory problems due to radiation exposure especially when avoiding the hippocampus area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a solid tumor with brain metastasis needing whole brain radiation.

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I am not pregnant.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

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

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I have been diagnosed with leptomeningeal disease.

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I am currently using or have used memantine or similar medications.

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I have had whole brain radiation therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2, 4, 6, 9, 12, 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2, 4, 6, 9, 12, 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 4, 6, 9, 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Secondary study objectives

Alopecia Rates between NTS-WBRT+SIB and NTS-WBRT

Change in Fatigue between NTS-WBRT+SIB and NTS-WBRT

Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Otoacoustic Emissions

+9 more

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: NTS-WBRT (normal tissue sparing whole brain radiation therapy) + MemantineExperimental Treatment2 Interventions

Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive: * NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks. * Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Memantine

2006

Completed Phase 4

~1200

0 / 7Eligibility criteria met