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