Spot Delete Technique for Skin Reactions in Head and Neck Cancer
Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy
Recruiting
N/AInterventional Study
Head and Neck CancerHead and Neck Squamous Cell CarcinomaHead and Neck Carcinoma
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
100 (estimated)
Sponsor
Covenant Health Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with certain types of head and neck cancer. Participants will receive a specific type of treatment called PBS proton therapy and will help researchers learn how to reduce skin reactions caused by this treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with squamous cell carcinoma in my head or neck.
I have signed a consent form to be in this study.
I am in a clinical stage that meets the study's criteria.
I can have had surgery for my cancer before.
I can have had chemotherapy before or during the study.
I do not have serious health conditions that would affect my treatment.
You may not be able to join if
I have had radiation therapy in the study area before.
I have had head and neck radiation that did not include lymph nodes.
I am a child.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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 (lin…
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 Criteria
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, o…
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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