RecruitingPhase 2NCT05075980

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers


Sponsor

Mayo Clinic

Enrollment

174 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called HEADLIGHT) is comparing proton beam therapy to standard X-ray radiation after surgery for head and neck cancer, to see if proton therapy causes fewer side effects while being equally effective. **You may be eligible if...** - You are 18 or older - You have a newly diagnosed, non-HPV-associated head or neck cancer (in the nasal cavity, sinuses, mouth, throat, larynx, or salivary glands) - Your cancer has not spread to other parts of the body (M0 confirmed by PET/CT) - Your general health is good (ECOG 0–1 before initial treatment) - You are willing to return to the study site for follow-up visits **You may NOT be eligible if...** - You have a serious coexisting illness that makes you a poor candidate for this study - Your cancer is HPV-related (except in specific situations) - You are not able to complete questionnaires or follow-up requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Given IV

PROCEDUREIntensity-Modulated Proton Therapy

Undergo IMPT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI or PET/MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT or PET/MRI

PROCEDUREBiospecimen Collection

Undergo blood sample collection

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT


Locations(9)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health System - Mankato

Mankato, Minnesota, United States

Mayo Clinic Radiation Therapy - Northfield

Northfield, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, United States

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05075980


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