RecruitingPhase 2NCT03215719

Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma

Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response

Sponsor

NYU Langone Health

Enrollment

120 participants

Start Date

Oct 18, 2017

Study Type

INTERVENTIONAL

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma Oropharyngeal Carcinoma

Summary

This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether patients with HPV-positive throat cancer who respond well to initial treatment can receive a reduced course of radiation therapy, to achieve similar cancer control with fewer side effects. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the oropharynx (throat), including the tonsils, base of tongue, soft palate, or back of the throat - Your cancer has tested positive for HPV (specifically the p16 protein marker) - Your cancer is considered favorable risk (early to moderate stage) - You are fit enough to complete the treatment **You may NOT be eligible if...** - Your throat cancer does not test positive for HPV (p16 negative) - Your cancer is at an advanced stage with a poor prognosis - You have previously received radiation to the head and neck area - You have other serious health conditions that prevent treatment 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

RADIATIONStandard Radiation Treatment

An interval scan at 4 weeks to assess for a good response defined as \>40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (\>40% nodal shrinkage). Those with nodal shrinkage and clearance of circulating plasma HPV DNA shall undergo further treatment de-escalation.

RADIATIONDose-Deescalated Treatment

Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons

DRUGCisplatinum

Standard of care chemotherapy

Locations(1)

New York University School of Medicine

New York, New York, United States

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NCT03215719

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