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Proton Beam Therapy
Proton Radiation Therapy for Brain Tumor
N/A
Recruiting
Led By Helen A Shih, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants indicated for proton radiation therapy
Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation, including low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma, and meningioma as common diagnoses
Must not have
History of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that limit compliance
Uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether or not proton radiation can be used to treat brain tumors.
Who is the study for?
Adults over 18 with benign or low-grade brain tumors who need radiation therapy can join this trial. They must be able to understand English, sign consent, use contraception if needed, and have a life expectancy of at least 6 months. People with severe illnesses, heart problems, psychiatric conditions that affect compliance, or pregnant/lactating women cannot participate.
What is being tested?
The study is testing Proton Radiation as a treatment for various types of brain tumors including glioma, pituitary adenoma, schwannoma, and meningioma. It's designed to see how well it controls tumor growth while assessing the impact on patients' quality of life and any side effects.
What are the potential side effects?
Proton Radiation may cause skin irritation at the treatment site, fatigue, headaches or hair loss in the treated area. Some people might experience nausea or difficulty with memory and concentration after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am recommended to undergo proton radiation therapy.
Select...
I have a diagnosed brain tumor that needs radiation, such as glioma or meningioma.
Select...
I am 18 years old or older.
Select...
I can care for myself but may need occasional help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have ongoing infections, heart issues, unstable angina, arrhythmias, or mental health/social situations that would affect my treatment compliance.
Select...
I do not have any unmanaged ongoing illnesses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of Local Control
Secondary study objectives
Alopecia
CD4 count
Neurocognitive effects
+6 moreAwards & 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: Proton RadiationExperimental Treatment1 Intervention
* Radiation therapy will be delivered typically five (5) days per week on weekdays
* Proton Radiation dose be determine by histology
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Radiation
2010
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,720 Total Patients Enrolled
Helen A Shih, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis was made based on scans and symptoms without a biopsy, as it's considered standard care.I am recommended to undergo proton radiation therapy.I do not have ongoing infections, heart issues, unstable angina, arrhythmias, or mental health/social situations that would affect my treatment compliance.I have a diagnosed brain tumor that needs radiation, such as glioma or meningioma.I have had cancer before, but it was a different type or treated long ago.I am 18 years old or older.I can care for myself but may need occasional help.I have had surgery or chemotherapy before.I agree to use effective birth control.I do not have any unmanaged ongoing illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Radiation
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.