Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05075980

Run by

Mayo Clinic

People needed

174

Starts

2022-02-16

Expected to finish

2031-03-05

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years
• Histological confirmation of a newly diagnosed non-human papillomavirus (HPV) associated malignant epithelial cancer in the head and/or neck. Diagnosis requires confirmation of p16 and/or HPV DNA negativity for oropharyngeal and unknown primary sites. p16 positivity in skin cancers is allowed
• Primary lesion located in the nasal cavity, paranasal sinuses, oral cavity, oropharynx, larynx, hypopharynx, salivary glands, lymph nodes (unknown primary or metastasis from head and neck [HN]-skin primary) or skin cancer where lymph node radiation is recommended
• NOTE: Patients with primary lesions in the larynx must have a T3 primary, bulky T2 primary (> 6 cc), and/or at least 1 regional lymph node
• Confirmation of American Joint Committee on Cancer (AJCC) 8th edition defined M0 established by positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status (0-1 prior to initial treatment)
• Able to provide written informed consent
• Able to complete questionnaires independently or with assistance
• Willing to return to enrolling institution for follow up during the observation phase

You may not qualify if…

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
• NOTE: Patients known to be HIV positive, but without clinical evidence of immunocompromised state, are eligible for this trial
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy =< 2 years prior to registration
• EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix and prostate cancer with a Gleason score of 6 or less
• NOTE: If there is a history or prior malignancy, they must not be receiving ongoing anticancer treatment
• History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Prior radiation therapy that would have a clinically significant overlap with the intended head/neck radiation
• For Arms A and B only: Unable to receive proton therapy because of extensive metallic hardware in close proximity to treatment site, logistical circumstances, or any other reason
• Any of the following diagnoses: HPV-associated squamous cell carcinoma, germ cell tumors, hematologic malignancies, neuroendocrine malignancies, adenoid cystic carcinoma, sarcomas of bone, benign tumors

Where it is running

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States
• Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States
• Mayo Clinic Radiation Therapy - Northfield — Northfield, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Mayo Clinic Health System - Eau Claire — Eau Claire, Wisconsin, United States
• Mayo Clinic Health System - Franciscan Healthcare — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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