Study on Shortened Radiation Therapy After Robotic Surgery for HPV-Related Throat Cancer

Sponsor: University of Utah

Sponsor score: 0

ClinicalTrials ID:NCT07044635

This clinical trial is exploring whether a shorter course of radiation therapy can improve the quality of life for patients who have undergone robotic surgery for HPV-related throat cancer.

Patient Parameters

Program Overview

The aim of this study is to see if a shorter duration of radiation therapy can enhance the quality of life for patients who have had trans-oral robotic surgery for HPV-related oropharyngeal squamous cell carcinoma, a type of throat cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with oropharyngeal squamous cell carcinoma (a type of throat cancer).
  • Eligible for robotic surgery through the mouth.
  • Cancer must be HPV positive, confirmed by specific tests on tumor samples.
  • Must have a pre-surgery HPV DNA test.
  • Standard medical tests completed within 60 days before joining the study can be used.
  • Must have a performance status score of 2 or less, indicating good overall health.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Previous head and neck cancer treated with radiation.
  • Other cancers that could interfere with this study.
  • Smoked cigarettes within one month before joining the study.
  • Recent cancer treatments within 14 days or less before starting the study.
  • Cancer that has spread to distant parts of the body.
  • Any condition that could make participating in the study unsafe or difficult, such as infections, inability to swallow medication, or psychological issues.
  • Medical or mental conditions that could affect understanding the study or following the study procedures.

Step 2 Registration - Experimental Arm

Inclusion Criteria:

  • Must have completed robotic surgery through the mouth.
  • Must have pre- and post-surgery HPV DNA test results.
  • Women of childbearing potential must have a negative pregnancy test or proof of permanent sterilization. Post-menopausal status is defined as no periods for 12 months without another medical reason.
  • Must agree to use effective birth control methods during the study.

Exclusion Criteria:

  • Meets all criteria for low-risk disease, such as specific test results and cancer characteristics.
  • Meets any criteria for high-risk disease, such as positive post-surgery HPV DNA test or certain cancer characteristics.
  • Any condition that could make participating in the study unsafe or difficult, such as infections, inability to swallow medication, or psychological issues.

Locations

FACILITYZIPCITYSTATE
Huntsman Cancer Institute/University of Utah84112Salt Lake CityUtah

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