Spots Global Cancer Trial Database for Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03215719

Conditions

Oropharyngeal Carcinoma

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Standard Radiation Treatment

Dose-Deescalated Treatment

Cisplatinum

Study Description

Brief 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.

Detailed 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.