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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | 84112 | Salt Lake City | Utah |
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