Study on Reducing Radiation Dose for HPV-Related Head and Neck Cancer
Sponsor: University of Virginia
ClinicalTrials ID:NCT05962242
This clinical trial is testing if a lower dose of radiation can safely and effectively treat head and neck cancers linked to HPV, with fewer side effects than standard radiation therapy.
Patient Parameters
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Program Overview
The study aims to find out if using a lower dose of radiation can effectively treat head and neck cancers caused by HPV, while reducing the unpleasant side effects often associated with standard radiation therapy. Researchers believe that a lower dose might be just as effective in preventing the cancer from coming back, but with less harm to the body.
Description
In this study, patients with HPV-positive head and neck cancer will receive a lower dose of radiation therapy than usual. This approach is based on evidence suggesting that less radiation might still prevent the cancer from returning, but with fewer side effects. The amount of radiation will be adjusted based on whether the patient is also receiving chemotherapy, results from a special HPV blood test, physical exams, and imaging scans. If the blood test shows a slow response to treatment, an extra boost of radiation may be given. Patients will also complete surveys about their health and wellbeing during the study.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent and agree to follow study procedures.
- Must be 18 years or older.
- Must have a confirmed diagnosis of squamous cell carcinoma of the oropharynx.
- Must be eligible for radiation therapy as a main or additional treatment.
- Can be receiving chemotherapy or immunotherapy for oropharyngeal cancer.
- Chemotherapy is optional for smaller tumors without lymph node involvement.
- Chemotherapy is required for larger tumors or those with lymph node involvement.
- May receive investigational drugs with approval.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must have HPV-positive cancer as confirmed by specific tests.
- Women of childbearing potential must agree to use contraception during and after treatment.
Exclusion Criteria
- Cancer has spread to distant parts of the body.
- Previous radiation treatment to the head or neck.
- Recent surgery for oropharyngeal cancer unless it was incomplete.
- Larger tumors or those with lymph node involvement without plans for chemotherapy.
- Other invasive cancers unless disease-free for at least 3 years.
- Currently in prison.
- Conditions that make radiation therapy unsafe, like certain genetic disorders.
- Pregnant or breastfeeding.
- Severe health issues, such as recent heart problems, infections, or liver disease.
- History of heavy smoking unless quit over a year ago.
- Currently using cancer drugs for other types of cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Miami Cancer Institute | 33176 | Miami | Florida |
| University of Virginia | 22908 | Charlottesville | Virginia |
| Eastern Virginia Medical School | 23507 | Norfolk | Virginia |
| Virginia Commonwealth University | 23284 | Richmond | Virginia |
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