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

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.

Trial Details

NCT ID
NCT03215719
Phase
PHASE2
Sponsor
NYU Langone Health
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Standard Radiation Treatment
  • Dose-Deescalated Treatment
  • Cisplatinum
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, bas…
  • If the primary site is biopsied, Patient's tissue must be positive for p16 by immunohistochemical staining (\>70% staining). Fine needle aspiration…
  • Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary…
  • Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases based on the following diagnostic workup:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HPV Positive Head and Neck Cancer Trials on Trialify →