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Proton Beam Therapy
Proton Radiation for Brain Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 18 years
Patients with WHO grade II tumors, either completely or incompletely excised, or any recurrent tumor
Must not have
Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
Prior radiation to the brain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether proton therapy is a safe and effective treatment for people with brain cancer.
Who is the study for?
This trial is for adults over 18 with WHO Grade I-III Meningioma & Hemangiopericytoma brain cancer. Participants must have adequate bone marrow function, not be pregnant or nursing, and agree to use birth control if of childbearing potential. They should not have had prior brain radiation or other cancers (with some exceptions) in the past two years.
What is being tested?
The study tests Proton radiotherapy's effectiveness and safety on patients with specific brain cancers. It includes a feasibility phase for 12 patients followed by a larger Phase II for an additional 38 patients, comparing results with existing photon therapy data.
What are the potential side effects?
While the summary doesn't specify side effects, proton radiation can generally cause fatigue, skin reactions at treatment sites, hair loss around treated areas, headaches and may temporarily worsen pre-existing symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My tumor is WHO grade II, may or may not be fully removed, or has come back.
Select...
My tumor is WHO grade III or a hemangiopericytoma, and it may not have been fully removed.
Select...
I can care for myself but cannot do normal activities or work.
Select...
My diagnosis is a type of brain tumor called meningioma or hemangiopericytoma.
Select...
My blood tests show enough white cells and platelets.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had any cancer other than skin or thyroid cancer in the past 2 years.
Select...
I have had radiation treatment to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility and Safety
Secondary study objectives
Cumulative total dose (Gy) to normal brain tissue
Fatigue - Brief Fatigue Inventory (BFI)
Health Related Quality of Life
+2 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
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?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,302 Total Patients Enrolled
1 Trials studying Meningioma
23 Patients Enrolled for Meningioma
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
463,775 Total Patients Enrolled
1 Trials studying Meningioma
23 Patients Enrolled for Meningioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My tumor is WHO grade II, may or may not be fully removed, or has come back.My tumor is WHO grade III or a hemangiopericytoma, and it may not have been fully removed.I have not had any cancer other than skin or thyroid cancer in the past 2 years.I am using birth control or am not of child-bearing age due to menopause or hysterectomy.My tumor is low grade, newly found, not fully removed, or has come back after surgery.I can care for myself but cannot do normal activities or work.My diagnosis is a type of brain tumor called meningioma or hemangiopericytoma.My blood tests show enough white cells and platelets.I have had radiation treatment to my brain.
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.