RecruitingPhase 2NCT05962242

HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma

Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck (RaDEN) in Squamous Cell Carcinoma of the Head and Neck


Sponsor

University of Virginia

Enrollment

90 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with HPV-positive throat cancer (oropharyngeal squamous cell carcinoma) who respond very well to radiation treatment can safely have their radiation dose reduced. The idea is that if a blood test shows the HPV DNA is clearing from the body during treatment, less radiation might be needed — reducing side effects while keeping the cancer under control. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of HPV-positive squamous cell carcinoma of the oropharynx (throat/tonsil area) - You are planned to receive definitive radiation therapy (with or without chemotherapy) - Your cancer tests positive for HPV (p16 positive) - You have an adequate performance status (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You have had prior radiation to the head or neck - You had surgery to remove the tumor within the past 8 months - You have another active cancer (except non-melanoma skin cancer) diagnosed within the past 3 years - You have a condition that makes radiation therapy dangerous, such as certain connective tissue diseases 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

RADIATIONRadiation Therapy

External Beam Radiation to Head and Neck


Locations(5)

Miami Cancer Institute

Miami, Florida, United States

University of Virginia

Charlottesville, Virginia, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Bon Secours

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05962242


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