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Oropharyngeal CarcinomaCancerRadiationDrugPhase 2

What this study is

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.

What's being tested

  • Standard Radiation Treatment

    Intervention · RADIATION

    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.

  • Dose-Deescalated Treatment

    Intervention · RADIATION

    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

  • Cisplatinum

    Intervention · DRUG

    Standard of care chemotherapy

Study details

Official title
Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response
Sponsor
NYU Langone Health
Conditions
Oropharyngeal Carcinoma · HPV Positive Oropharyngeal Squamous Cell Carcinoma
Enrolling
120 people
Starts
2017-10-18
Est. completion
2028-12
Design
Open-label, non-randomized, sequential groups, Phase 2
Record
View on ClinicalTrials.gov ↗