Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

Running, not enrolling · Phase 1

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Oral Cavity

In brief

This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Key facts

Study ID

NCT05540899

Run by

American College of Radiology

People needed

14

Starts

2023-11-08

Expected to finish

2028-11-01

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
• Clinical stage I-IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
• General history and physical examination prior to registration;
• Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.
• Total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer).
• One or more indications for postoperative radiotherapy, based upon pathologic findings:
• Perineural invasion;
• Lymphovascular invasion;
• Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular Extension);
• Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin);
• Pathologically confirmed T3 or T4a primary tumor;
• T2 oral cavity cancer with ≥ 5 mm depth of invasion.
• Zubrod Performance Status 0-1.
• Age 18-80.
• Negative pregnancy test within 14 days prior to registration for participants who may become pregnant.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

You may not qualify if…

• Recurrence of the study cancer.
• History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
• Pregnancy and individuals unwilling to discontinue nursing.
• Reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration
• Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.
• Per the operative and/or pathology report, positive margin(s) [defined as tumor present at the cut or inked edge of the tumor], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.

Where it is running

• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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