Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study
NCT05075980 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2026-04-13
Summary
This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.
Conditions
- Head and Neck Carcinoma
- Head and Neck Carcinoma of Unknown Primary
- Hypopharyngeal Carcinoma
- Laryngeal Carcinoma
- Metastatic Malignant Neoplasm in the Lymph Nodes
- Nasal Cavity Carcinoma
- Oral Cavity Carcinoma
- Oropharyngeal Carcinoma
- Paranasal Sinus Carcinoma
- Salivary Gland Carcinoma
- Cutaneous Squamous Cell Carcinoma of the Head and Neck
- Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Interventions
- DRUG
-
Given IV
- PROCEDURE
-
Intensity-Modulated Proton Therapy
Undergo IMPT
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- PROCEDURE
-
Computed Tomography
Undergo CT or PET/CT
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI or PET/MRI
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT or PET/MRI
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- RADIATION
-
Intensity-Modulated Radiation Therapy
Undergo IMRT
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Scott C. Lester, M.D. · Mayo Clinic in Rochester
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-16
- Primary Completion
- 2027-11-15
- Completion
- 2035-11-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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