What side effects are associated with this type of intervention?

Common side effects of radiation therapy for pituitary adenomas include fatigue, headaches, hair loss at the treatment site, and skin changes. Hypofractionated proton or photon radiation therapy, which delivers higher doses over a shorter period, may also cause acute side effects such as nausea and vomiting. However, this approach aims to reduce long-term effects like cognitive deficits or secondary malignancies by shortening the overall treatment duration.

What prior FDA approvals exist?

The FDA has approved various treatments for pituitary adenomas, including surgical resection, medical therapies, and radiation therapy. Traditional radiation therapy, such as conventional fractionated radiotherapy, has been a standard approach. More recently, advanced techniques like stereotactic radiosurgery (e.g., Gamma Knife, CyberKnife) and proton beam therapy have gained approval and are used to deliver precise, high-dose radiation to the tumor while minimizing damage to surrounding tissues. These methods align with the principles of hypofractionated radiation therapy, which aims to deliver higher doses over a shorter period to enhance tumor control and reduce delayed side effects.

What other types of research exist?

Promising novel alternatives to hypofractionated proton or photon radiation therapy for pituitary adenomas include: 1) Stereotactic radiosurgery (SRS), which delivers precise, high-dose radiation in a single or few sessions, potentially reducing side effects and improving outcomes. 2) Image-guided, intensity-modulated radiation therapy (IG-IMRT), which allows for more accurate targeting of the tumor while sparing surrounding healthy tissue. 3) Endoscopic endonasal surgery, a minimally invasive surgical approach that provides direct access to the tumor with reduced recovery time and complications. 4) Molecular targeted therapies, which involve drugs designed to specifically target molecular pathways involved in tumor growth, offering a non-invasive treatment option.

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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

No Placebo-Only Group

Summary

This trial studies how well a new form of radiation therapy works for patients with certain types of brain tumors. The goal is to see if this method can effectively control tumor growth while reducing side effects and making treatment more convenient.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

local tumor control

Secondary study objectives

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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~160

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 2Eligibility criteria met

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.