NCT06183268Recruiting
Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy
Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Dec 2023
- Start date
- 13 Dec 2023
- Primary completion date
- 2 Jan 2028
- Lead sponsor
- Covenant Health Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06183268
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 13 Dec 2023 to the primary completion date, 2 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Children
- Women who are pregnant.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thompson Proton Center Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.