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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2, 4, 6, 9, 12, 18 and 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,449 Total Patients Enrolled
Helen A Shih, MD, MS, MPHPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with leptomeningeal disease.My doctor may allow previous targeted brain radiation.I've had brain radiation, but less than half of my brain was treated, as decided by my doctor.I do not have any severe illnesses that could affect my thinking or compliance with the study.I have a solid tumor with brain metastasis needing whole brain radiation.I had a craniotomy, and my doctor agrees I can join the trial if it's been 2 weeks since the surgery.I am not pregnant.My doctor agrees to any additional treatments alongside or after my radiotherapy.I am currently using or have used memantine or similar medications.I am 18 years old or older.I have had whole brain radiation therapy before.I am able to care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of participants being included in this trial?
"Yes, indeed. According to clinicaltrials.gov, this research is still looking for participants with the trial first posted on February 8th 2022 and recently edited April 7th 2022. The study requires 100 volunteer from 1 medical centre."
Answered by AI
What have been the findings of past experiments involving NTS-WBRT?
"Currently, 24 studies are underway to analyze the effects of normal tissue sparing whole brain radiation therapy (NTS-WBRT). 11 of these clinical trials have reached Phase 3. Though a majority of the experiments occur in Columbus, Ohio, there are 308 different sites running tests for this form of treatment."
Answered by AI
Are there any current opportunities to participate in this clinical trial?
"Yes, the data available on clinicaltrials.gov indicates that this medical study is still seeking participants. It was initially posted on February 8th 2022 and most recently updated April 7th 2222; 100 subjects are needed from a single location."
Answered by AI
What end-result does this research endeavor seek to achieve?
"This 4-month trial is primarily aimed at assessing the difference in patient-reported symptom burden between NTS-WBRT (normal tissue sparing whole brain radiation therapy) and HA-WBRT (hippocampal avoidance whole brain radiation Therapy). Secondary objectives are to analyse treatment related adverse events, changes in hearing as assessed by word recognition scores and otoacoustic emissions."
Answered by AI
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