HYPORT: Study on Shortened Radiation Therapy After Surgery for Head and Neck Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT04403620

Provider View

This clinical trial is exploring a new approach to radiation therapy for patients with head and neck cancer who have had surgery. The study aims to determine if a shorter course of radiation therapy is as effective and safe as the traditional longer course, focusing on the impact on swallowing and overall quality of life.

Patient Parameters

Program Overview

The purpose of this study is to test a new way of giving radiation therapy to patients with head and neck cancer after surgery. The study will compare a shorter, more intense course of radiation therapy to the standard longer course to see if it is just as effective and safe. The first part of the study will find the best dose for the shorter therapy, while the second part will compare the two methods in terms of swallowing ability and side effects.

Description

This study is for patients with head and neck cancer who have had surgery and need radiation therapy afterward. It focuses on cancers of the mouth, throat, and voice box. The study will test a shorter, more intense radiation therapy schedule to see if it works as well as the standard longer schedule. In the first phase, researchers will determine the best dose for the shorter therapy. In the second phase, patients will be randomly assigned to receive either the standard 6-week radiation therapy or the shorter 3-week therapy. The goal is to see if the shorter therapy is just as effective and has similar side effects, especially regarding swallowing and quality of life.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage I-IVB squamous cell carcinoma of the mouth, throat, or voice box, and have had surgery to remove the cancer.
  • Have certain risk factors that suggest the need for radiation therapy after surgery, such as larger tumors, affected lymph nodes, or specific types of cancer spread.
  • Be 18 years or older.
  • Be in good general health, with a performance status score of 0 to 2, meaning fully active or able to do light work.
  • Women and men must agree to use effective birth control during the study and for 90 days after completing therapy.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

Phase I:

  • Cancer has spread to distant parts of the body.
  • Have stage I or II glottic cancer.
  • Need chemotherapy due to high-risk factors after surgery.
  • Depend on a feeding tube at the start of the study.
  • 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 previous radiation therapy to the same area.
  • Are taking other experimental cancer treatments.
  • Have uncontrolled health issues, such as heart problems or infections.
  • Are pregnant or breastfeeding.
  • Have a history of severe immune system problems.

Phase II:

  • Same as Phase I, except patients who depend on a feeding tube can participate and will be grouped accordingly.

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