Study Comparing Two Types of Neck Radiation Therapy for Head and Neck Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06477692

Provider View

This clinical trial is exploring whether a new, more targeted radiation therapy can reduce side effects compared to the standard treatment for patients with certain types of head and neck cancer.

Patient Parameters

Program Overview

The study aims to find out if a new type of radiation therapy, which targets only the cancerous lymph nodes, is as effective as the standard treatment that targets a larger area. The new method uses advanced technology to focus on potentially cancerous nodes, which may help reduce damage to healthy tissue and decrease side effects. Participants will be randomly assigned to receive either the standard treatment or the new targeted therapy, and they will not know which treatment they are receiving during the study.

Description

In this study, patients with certain types of head and neck cancer will receive one of two types of radiation therapy. The standard treatment, called elective nodal irradiation (ENI), targets a broad area of lymph nodes. The new treatment, called involved nodal radiotherapy (INRT), focuses only on the lymph nodes that are likely to be cancerous, using a special AI program to identify them. The goal is to see if INRT can reduce side effects by sparing healthy tissue from radiation. Participants will be randomly assigned to one of the two treatments and will not know which one they are receiving. The study will compare the effectiveness and side effects of the two approaches.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (not from an unknown primary source).
  • Have visible cancer at the primary site or in lymph nodes, confirmed by scans or a small biopsy.
  • May have had a small surgery for early-stage tonsil or base of tongue cancer.
  • Cancer stage I-IVB, except for early-stage glottic cancer.
  • Aged 18 or older.
  • In good general health, able to carry out normal activities or light work.
  • Agree to use effective birth control during the study and for 90 days after treatment.
  • Women must not be pregnant and must agree to pregnancy testing.
  • Must have had specific scans (CT, MRI, PET-CT) of the neck.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Cancer has spread to distant parts of the body.
  • Unable to have necessary scans with contrast dye.
  • Have early-stage glottic cancer.
  • Have had complete removal of both primary and nodal cancer.
  • Have another active cancer outside the head and neck area, except for certain low-risk cancers.
  • Have had another invasive cancer within the last 3 years.
  • Have had chemotherapy for the current cancer (previous chemotherapy for another cancer is allowed).
  • Have had radiation therapy to the same area that would overlap with the study treatment.
  • Currently taking other experimental drugs.
  • Have allergies to similar drugs used in the study.
  • Have uncontrolled health issues like infections, heart problems, or mental health conditions that could interfere with the study.
  • Have a history of severe immune system issues, including HIV or past transplants.

Locations

FACILITYZIPCITYSTATE
UT Southwestern Medical Center75390DallasTexas

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