← Back to Search

Proton Beam Therapy

Personalized Radiotherapy for Head and Neck Cancer (PULS-Pal Trial)

N/A

Waitlist Available

Led By Travis Courtney, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be >= 18 years old

Diagnosis of primary or recurrent, localized or metastatic head and neck cancer (AJCC 8th Edition stages I-IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial evaluates how combining personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) with HyperArc radiation treatment planning technology can help control tumors in patients with head and neck cancer.

Who is the study for?

This trial is for patients with primary or recurrent head and neck cancer who can't have or don't want standard treatments. It's focused on palliative care, aiming to control symptoms and pain rather than cure the disease.

What is being tested?

Researchers are testing a combination of personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) with HyperArc technology. They hope this will deliver higher doses of radiation more effectively to tumors with fewer side effects.

What are the potential side effects?

While specific side effects aren't listed, radiation therapy like PULSAR may cause skin irritation, fatigue, dry mouth, difficulty swallowing, and changes in taste. The goal is to minimize these compared to standard lower-dose treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with head and neck cancer at any stage.

Select...

I am not eligible for or have chosen not to undergo standard treatments.

Select...

My largest tumor or the area it was in is smaller than 10cm.

Select...

I am a woman who can have children and have a recent negative pregnancy test.

Select...

I have a tracheostomy or a feeding tube and can join the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to progression of the treated tumor target

Secondary study objectives

Disease progression free survival (PFS)

Grade 3 or higher treatment-related toxicity

Incidence of adverse events (AE)

+5 more

Awards & 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: Treatment (PULSAR and HyperArc)Experimental Treatment8 Interventions

Patients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Volume Modulated Arc Therapy

2017

Completed Early Phase 1

~30

Computed Tomography

2017

Completed Phase 2

~2790