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

RecruitingNAAges 18 Years - anyAllCovenant Health Cancer Center
NCT06183268 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Spot Delete
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Where

1 site
Thompson Proton Center
Knoxville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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