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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

HiPPI Trial 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.

HiPPI Trial 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.

HiPPI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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 2022 Phase 2 trial • 107 Patients • NCT03324802

80%

Dermatitis radiation

54%

Skin hyperpigmentation

48%

Pain

35%

Lymphedema

22%

Superficial soft tissue fibrosis

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

HiPPI 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 2

~130

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,626 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,935 Total Patients Enrolled

Bree R EatonPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

$Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04278118 — N/A$

$Pituitary Adenomas Research Study Groups: Cohort I (hypofractionated radiation therapy), Cohort II (hypofractionated radiation therapy)$

$Pituitary Adenomas Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04278118 — N/A$

$Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278118 — N/A$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients eligible to join this clinical investigation?

"Affirmative. According to the information hosted on clinicaltrials.gov, this investigation is currently recruiting subjects; it was launched on February 18th 2020 and revised most recently on May 24th 2022. 70 volunteers are expected from 1 site."

Answered by AI

What is the scope of participant involvement in this research endeavor?

"Affirmative. Clinicaltrials.gov states that this trial is actively recruiting, first posted on February 18th 2020 and recently updated on May 24th 2022. 70 participants are sought from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study

Bree Eaton 2020. "Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278118.

All > Brain Tumor > Meningioma