Study on Reducing Radiation Dose After Robotic Surgery for HPV-Positive Throat Cancer

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05387915

Provider View

This clinical trial is exploring whether using a lower dose of radiation therapy after robotic surgery can help improve swallowing and quality of life for patients with HPV-positive throat cancer, compared to the standard radiation dose.

Patient Parameters

Program Overview

This study is testing if a lower dose of radiation therapy, given after robotic surgery, is effective in treating patients with HPV-positive throat cancer. HPV-positive throat cancer generally has a better outlook than other types. The usual treatment involves surgery followed by radiation, but this can lead to long-term side effects like difficulty swallowing. By reducing the radiation dose, the study aims to improve swallowing and overall quality of life for patients.

Description

The main goal of this study is to see how well patients can swallow after receiving a lower dose of radiation therapy following surgery, compared to past patients who received the standard dose. The study will also look at how long patients live without the cancer coming back and how well the cancer is controlled in the throat area.

Patients who test negative for a specific HPV marker in their blood after surgery will receive a reduced dose of radiation therapy over three weeks. Those who test positive will receive the standard radiation therapy. After treatment, patients will have follow-up visits at 3, 6, 12, 18, and 24 months to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status, able to carry out daily activities.
  • Expected to live more than 12 weeks.
  • Diagnosed with HPV-positive throat cancer.
  • Have a smoking history of 10 pack-years or less.
  • Completed robotic surgery and neck dissection by a qualified surgeon.
  • Have certain risk factors in the cancer tissue, like close margins or specific types of invasion.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study.
  • Must be willing to follow study procedures and attend scheduled visits.
  • Must sign an informed consent form acknowledging understanding of the study and its potential risks and benefits.

Exclusion Criteria

  • Have had another cancer in the last two years, except for certain skin cancers.
  • Have had chemotherapy or radiation within the last four weeks and not fully recovered from side effects.
  • Are participating in another clinical trial or using investigational drugs.
  • Have uncontrolled health issues like infections, heart problems, or mental health conditions that could affect study participation.
  • Have had significant heart or blood vessel problems in the last three months, or have uncontrolled high blood pressure.

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