Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCovenant Health Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Spot Delete
RadiationThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
"Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.
Aim to test the hypothesis that the "Spot Delete" technique in proton therapy reduces radiation dermatitis in head \& neck cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. To evaluate this, the investigators will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment.
Time frame
Weekly Assessments over 10 weeks, 1 month and 6 months post treatmentSecondary outcomes
1
To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions.
It is unknown if there is a correlation between the LET lines and the observed skin reactions. To answer this question, LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions.
Time frame
comparisons to be conducted over a 5 year periodSponsors and contacts
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Source ClinicalTrials.gov