Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909
Actively Recruiting
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
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