RecruitingPhase 2NCT05075980

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

HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers


Sponsor

Mayo Clinic

Enrollment

174 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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

Exclusion Criteria12

  • 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

Interventions

DRUGCisplatin

Given IV

PROCEDUREIntensity-Modulated Proton Therapy

Undergo IMPT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI or PET/MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT or PET/MRI

PROCEDUREBiospecimen Collection

Undergo blood sample collection

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT


Locations(9)

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

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NCT05075980


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