RecruitingPhase 2NCT06088381

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Sponsor

University of Maryland, Baltimore

Enrollment

61 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Head and Neck Squamous Cell Carcinoma HPV Positive Oropharyngeal Squamous Cell Carcinoma Oropharynx Cancer Oropharynx Squamous Cell Carcinoma

Summary

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with HPV-related throat cancer (oropharynx) who have high levels of circulating tumor DNA in their blood after surgery still benefit from additional radiation therapy, while those with low levels may be able to safely skip it. Researchers hope to personalize treatment and avoid unnecessary side effects for some patients. **You may be eligible if...** - You have been diagnosed with p16-positive (HPV-related) squamous cell carcinoma of the oropharynx or an unknown primary tumor - Your cancer is early to intermediate stage (T0–T3, N0–N1, M0 per AJCC 8th edition) - Your blood test (ctDNA) showed detectable tumor DNA before treatment - You are planned for surgery to remove the cancer **You may NOT be eligible if...** - Your tumor is HPV-negative - Your cancer has spread to distant organs - You have had prior radiation to the head and neck area - You have serious medical conditions that prevent surgery or radiation 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

OTHERExperimental Observation

Patients on the experimental arm will be under observation only.

OTHERObservation per Standard of Care

The low-risk group of patients will be observed per standard of care.

RADIATIONAdjuvant Treatment per Standard of Care

The high-risk group of patients will receive adjuvant treatment per standard of care (Radiation with or without chemotherapy)

DIAGNOSTIC_TESTCirculating Tumor DNA test (ctDNA test)

Blood test for diagnostic and surveillance purposes measuring expression of Cell free HPV tumor DNA (ctDNA) in the blood. Patients will undergo ctDNA within 90 days pre-transoral robotic surgery(TORS), 2-14 days post TORS, then every 3 months (except for at 21 months) for 2 year post completion of initial therapy or salvage therapy.