Status:
RECRUITING
Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy
Lead Sponsor:
Thompson Cancer Survival Center
Conditions:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 "...
Detailed Description
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 "...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06183268
Start Date
December 13 2023
End Date
January 2 2030
Last Update
April 8 2025
Active Locations (1)
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1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909