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

NCT05075980 | Active Not Recruiting Phase 2 FDA Device

• 3 other identifiers: GMROR2171NCI-2021-0970621-000973
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 9

Brief 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; Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck; 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

Outcome Measures

Primary Outcomes (1)

• Rate of local/regional control (LRF)

  The 2-year LRF rate will be estimated by counting the number of patients with a local or regional failure and dividing by the total number of eligible patients.

  At 2 years

Secondary Outcomes (11)

• Incidence of acute adverse events

  Up to 3 months after radiation therapy

• Incidence of late adverse events

  Up to 3 years after completion of radiation therapy

• Incidence of secondary acute effects attributable to radiation therapy

  Up to 3 months after completion of radiation therapy

• Quality of life (QOL) and financial burden - MDADI

  Up to 10 years

• Quality of life (QOL) and financial burden - EQ-5D-5L

  Up to 10 years

Study Arms (3)

Arm A (IMPT, IMRT, cisplatin)

EXPERIMENTAL

Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Drug: Cisplatin; Procedure: Intensity-Modulated Proton Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Biospecimen Collection; Radiation: Intensity-Modulated Radiation Therapy

Arm B (IMPT, cisplatin)

EXPERIMENTAL

Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Drug: Cisplatin; Procedure: Intensity-Modulated Proton Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Biospecimen Collection

Arm C (IMRT, cisplatin)

EXPERIMENTAL

Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.

Drug: Cisplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Biospecimen Collection; Radiation: Intensity-Modulated Radiation Therapy

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Intensity-Modulated Proton Therapy PROCEDURE

Undergo IMPT

Also known as: IMPT

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin)

Questionnaire Administration OTHER

Ancillary studies

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI or PET/MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Positron Emission Tomography PROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Specimen Collection

Arm A (IMPT, IMRT, cisplatin); Arm B (IMPT, cisplatin); Arm C (IMRT, cisplatin)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Intensity Modulated X-ray Therapy

Arm A (IMPT, IMRT, cisplatin); Arm C (IMRT, cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (9)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic Radiation Therapy - Northfield

Northfield, Minnesota, 55057, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Lymphatic Metastasis; Mouth Neoplasms; Oropharyngeal Neoplasms; Paranasal Sinus Neoplasms; Salivary Gland Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Magnetic Resonance Spectroscopy; X-Rays; Specimen Handling; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Nose Neoplasms; Nose Diseases; Paranasal Sinus Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Scott C. Lester, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 13, 2021
• Study Start: February 16, 2022
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2035
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (9)