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

HPV Positive Oropharyngeal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Summary

This will be a phase II single-arm 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.

Clinical Trial Description

The secondary objectives will include 2-year loco-regional control and overall survival, quality of life, and late toxicity. Quality of life outcomes will be assessed with a validated, self-reported questionnaire. Late toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03215719
Study type Interventional
Source NYU Langone Health
Contact Kenneth Hu
Phone 212-731-5003
Email Kenneth.Hu@nyulangone.org
Status Recruiting
Phase Phase 2
Start date July 10, 2017
Completion date December 2025
View Details
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