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Proton Therapy for Brain Tumors (HiPPI Trial)

N/A
Recruiting
Led By Bree R Eaton
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recommended to receive proton or photon fractionated radiation therapy
Be older than 18 years old
Must not have
Prior radiation therapy that would overlap with current target volume
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is testing how well two types of radiation therapy work in treating brain tumors. One type is given over a shorter period of time and may be more convenient and less costly.

Who is the study for?
This trial is for individuals with benign brain tumors, including meningiomas, pituitary adenomas, and schwannomas. Participants must consent to treatment and be recommended for proton or photon radiation therapy. Pregnant women can't join, and women who can have children must test negative for pregnancy and agree to use effective birth control.Check my eligibility
What is being tested?
The HiPPI Study is testing if hypofractionated proton or photon radiation therapy is effective in treating benign brain tumors by delivering higher doses over a shorter period. The goal is to see if this approach kills more tumor cells while reducing side effects and costs.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation therapy such as fatigue, skin irritation at the treatment site, headaches, hair loss around the treated area, nausea, and potential short-term memory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am advised to undergo a specific type of radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy in the same area where I need treatment now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
local tumor control
Secondary outcome measures
Health related quality of life
Neurocognitive effects

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (hypofractionated radiation therapy)Experimental Treatment5 Interventions
Patients with pathologically confirmed World Health Organization (WHO) grade 2-3 meningiomas undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 20 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (hypofractionated radiation therapy)Experimental Treatment5 Interventions
Patients with benign and radiographically diagnosed intracranial tumors undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 17 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for pituitary adenomas include surgical resection, medical therapy, and radiation therapy. Hypofractionated proton or photon radiation therapy, a focus of recent studies, delivers higher doses of radiation over a shorter period to kill more tumor cells effectively. This method is particularly important for pituitary adenoma patients as it can reduce the overall treatment duration, minimize delayed side effects, and improve patient convenience. Proton therapy, in particular, offers high precision, sparing surrounding healthy tissues and reducing the risk of damage to critical brain structures near the pituitary gland.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,655 Previous Clinical Trials
2,572,413 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,331 Total Patients Enrolled
Bree R EatonPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04278118 — N/A
Pituitary Adenomas Research Study Groups: Cohort I (hypofractionated radiation therapy), Cohort II (hypofractionated radiation therapy)
Pituitary Adenomas Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04278118 — N/A
Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278118 — N/A
~13 spots leftby Jul 2025