RecruitingPhase 2NCT05541016

De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA

DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy


Sponsor

Mayo Clinic

Enrollment

455 participants

Start Date

Feb 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether radiation therapy doses can be safely reduced (de-escalated) for patients with oropharyngeal (throat) cancer, guided by a blood test called ctHPV-DNA that detects tiny fragments of HPV-associated cancer DNA in the bloodstream. The idea is that patients whose blood test turns negative quickly after treatment may need less radiation, reducing long-term side effects like dry mouth and swallowing difficulty. **You may be eligible if:** - You are 18 years or older - You have confirmed (or highly suspected) squamous cell carcinoma of the oropharynx (back of the throat, tonsils, base of tongue) - You are planned for surgery with curative intent, OR chemoradiation with cisplatin - No evidence of distant spread on imaging within the past 16 weeks - Your general health is good (ECOG score 0–1) **You may NOT be eligible if:** - Your cancer has spread to distant sites - You are ineligible for cisplatin-based chemotherapy - You are pregnant - You are unable to participate in all required follow-up visits 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 and saliva specimen collection for NavDx testing

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

RADIATIONDiffusing Alpha-emitter Radiation Therapy

Undergo DART

DRUGDocetaxel

Given IV

PROCEDUREIntensity-Modulated Proton Therapy

Undergo IMPT

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREModified Barium Swallow Study

Undergo MBSS

OTHERObservation Activity

Undergo observation

PROCEDUREPositron Emission Tomography

Undergo PET scan

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire

Ancillary studies


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05541016


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