Comparing proton and X-ray therapy after surgery for head and neck cancer
HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers
PHASE2 · Mayo Clinic · NCT05075980
This study is testing whether proton therapy or X-ray therapy works better for people who have had surgery for head and neck cancer, looking at how well they recover and their quality of life.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 9 sites (Phoenix, Arizona and 8 other locations) |
| Trial ID | NCT05075980 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intensity modulated proton therapy (IMPT) versus intensity modulated X-ray therapy (IMRT) in patients who have undergone surgery for head and neck cancer. The study aims to assess local-regional control, overall survival, and quality of life among participants over a two-year period. It also investigates treatment-related side effects and the impact of therapy on patient-reported outcomes. By comparing these two radiation therapies, the trial seeks to determine which method may provide better results with fewer adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed non-HPV associated malignant epithelial cancers in the head and neck region.
Not a fit: Patients with HPV-associated cancers or those with primary lesions not located in the specified areas may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced side effects for patients with head and neck cancer.
How similar studies have performed: Previous studies have shown promising results with both IMPT and IMRT, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Phoenix, Arizona and 8 other locations
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (RECRUITING)
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (RECRUITING)
- Mayo Clinic Radiation Therapy - Northfield — Northfield, Minnesota, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System - Eau Claire — Eau Claire, Wisconsin, United States (RECRUITING)
- Mayo Clinic Health System - Franciscan Healthcare — La Crosse, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Scott C. Lester, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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