RecruitingPhase 2NCT06323460

Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

A Pilot Study of Adaptive De-Intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

45 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized approach to radiation therapy for HPV-related throat cancer (oropharyngeal cancer). Instead of giving everyone the same radiation dose, doctors will use a blood test that measures tumor DNA to decide whether it is safe to reduce the radiation dose. The goal is to lessen side effects in patients who respond well to treatment. **You may be eligible if:** - You have been diagnosed with squamous cell cancer of the oropharynx (throat, tonsils, base of tongue, or soft palate) - Your cancer tested positive for P16 (a marker linked to HPV-related cancer) - Your cancer is classified as stage T0–T4, N0–N2 without distant spread - You have not yet received treatment for this cancer **You may NOT be eligible if:** - Your cancer has spread to distant organs - Your tumor does not test P16-positive - You have had prior head and neck radiation - You are unable to complete required imaging and blood tests 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

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo PET/CT

RADIATIONExternal Beam Radiation Therapy

Undergo external beam radiotherapy

DRUGPaclitaxel

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06323460


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