RecruitingNot ApplicableNCT04667585

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT

Sponsor

Duke University

Enrollment

120 participants

Start Date

Apr 12, 2021

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the radiation dose for treating HPV-related throat (oropharyngeal) cancer can be safely reduced without compromising how well the cancer is controlled. Since HPV-positive throat cancers tend to respond better to treatment, researchers believe a lower radiation dose may work just as well with fewer side effects. **You may be eligible if you:** - Have been diagnosed with squamous cell carcinoma of the throat (oropharynx) that is HPV-positive (confirmed by p16 staining or HPV testing) - Have Stage I–III disease and are planned to receive chemotherapy alongside radiation - Are in good health (ECOG performance status 0–1) - Have not lost more than 10% of your body weight in the past 3 months - Are 18 years of age or older - Have not received chemotherapy for your current cancer **You may NOT be eligible if you:** - Have previously received radiation to the head and neck - Have cancer that has spread to distant parts of the body - Have medical conditions that prevent radiation therapy - Have had another active cancer in the past few years (other than certain skin cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDe-escalated radiation dose

Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced

RADIATIONStandard radiation dose

Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

OTHER18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.