Study on Preserving Swallowing Ability in Oral Cavity Cancer Patients: Comparing Radiation Treatments

Sponsor: Lawson Health Research Institute

Sponsor score: 0

ClinicalTrials ID:NCT03997643

Provider View

This clinical trial is comparing two different radiation therapy approaches to see which one better preserves quality of life, particularly swallowing ability, in patients who have had surgery for oral cavity cancer.

Patient Parameters

Program Overview

The purpose of this study is to compare the quality of life in patients who have had surgery for oral cavity cancer and are receiving either standard radiation therapy or a more targeted radiation therapy. The study aims to provide strong evidence to help doctors choose the best treatment option for preserving swallowing ability and overall quality of life.

Description

This study involves patients who have had surgery to remove oral cavity cancer and are now receiving radiation therapy. The trial will compare two groups: one receiving standard radiation therapy to the tumor area and surrounding tissues, and the other receiving targeted radiation therapy focused only on the tumor area. A total of 90 patients will participate, with 60 receiving targeted therapy and 30 receiving standard therapy. Participants will be monitored for five years to assess their quality of life, especially their ability to swallow.

Eligibility Criteria

Inclusion Criteria

  • Willing to give informed consent to participate.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Diagnosed with oral cavity squamous cell carcinoma that has been surgically removed, with specific neck dissection criteria met.
  • Have certain pathological features that suggest radiation therapy is needed, as recommended by their doctor.
  • Have at least one side of the neck with no cancer in the lymph nodes, confirmed by examining at least 10 nodes.

Exclusion Criteria

  • Have serious medical conditions or other reasons that make radiation therapy unsafe.
  • Have had head and neck cancer within the last five years.
  • Have any other active invasive cancer, except for certain skin cancers.
  • Have had previous radiation therapy to the head and neck.
  • Have had previous cancer surgery in the oral cavity or neck.
  • Have cancer that has spread to other parts of the body.
  • Have cancer that has returned after surgery but before starting radiation therapy.
  • Unable to attend all radiation therapy sessions or follow-up visits.
  • Unable or unwilling to complete quality of life questionnaires.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Miami Cancer Institute33143MiamiFlorida

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