Recruiting

PBS Proton Therapy

Sponsor:

Thompson Cancer Survival Center

Code:

NCT06183268

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spot Delete

Study Details

Brief summary:

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

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Head and Neck Carcinoma

Study ID

NCT06183268

Start date

Dec 13, 2023

Status verified date

Apr, 2025

Completion date

Jan 2, 2030

Anticipated

Primary completion date

Jan 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

Spot Delete

The treatments plans will utilize the scripted spot delete method to remove spots from the skin rind. To ensure all relevant skin spots are removed, the "SkinSpots" structure will be a 0.5 cm rind extending inward from the skin contour within 5 cm of the CTV. Spots will be removed from this structure and optimization will continue. Optimization objectives will be utilized to spare the skin rind structure during treatment planning, in addition to deleting spots.

Primary outcome measure

  • "Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients. [ Time Frame: Weekly Assessments over 10 weeks, 1 month and 6 months post treatment ]

Central Contacts and Locations

Central contacts

Samantha Hedrick, PhD, DABR

865-862-1600shedrick@CovHlth.com

Catherine Duke-Taylor, BS

865-862-1600cduke@CovHlth.com

Locations

Thompson Proton Center

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Catherine Duke-Taylor, BS

865-331-8216cduke@CovHlth.com

Jessica M Severt, RN, BSN

865-331-4966jsevert@covhlth.com

Principal Investigator:

Samantha Hedrick, PhD

More Information

Sponsor

Thompson Cancer Survival Center

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thompson Cancer Survival Center on 2025-04-08.