Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06183268

Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy

Led by Covenant Health Cancer Center · Updated on 2025-04-08

100

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for head \& neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.

CONDITIONS

Official Title

Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
  • Patients must be ≥ 18 years old.
  • Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx
  • Carcinoma of the neck of unknown primary site origin may be included if p16 positive
  • Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases
  • Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time
  • Previous or concurrent chemotherapy is allowed
  • No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment
Not Eligible

You will not qualify if you...

  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Head and neck radiotherapy that does NOT include at least one cervical lymph node level (I, II, III, IV, or V) in the target volume.
  • Children
  • Women who are pregnant.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Thompson Proton Center

Knoxville, Tennessee, United States, 37909

Actively Recruiting

Loading map...

Research Team

S

Samantha Hedrick, PhD, DABR

CONTACT

C

Catherine Duke-Taylor, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here