HEAD AND NECK: Oropharynx: HPV+: Early Stage: XRT: HN 005

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Title
NRG Oncology HN005 (Oropharynx deintensification)
Study Title

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Site Link
Malignancy
Head and Neck, Oropharyx, Oropharyngeal cancer
Stage
Disease Setting
Definitive chemoradiation
Line Of Therapy
N/A
Investigational Agent
Reduced dose radiation with chemo or IO
Drug Class
XRT
PI
Noam VanderWalde, MD
Sponsor
NRG Oncology
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Squamous cell carcinoma of the oropharynx
  • Measurable disease either in primary or lymph node
  • P16 posotive locally
  • T1-2N1M0 or T3N0-1M0
  • No more than 10 pack years of smoking history
  • ECOG PS 0-1
  • No T4 or N2
  • No recurrent disease
  • No supraclavicular nodes
  • No prior malignancy unless disease free for at least 3 years
  • No allergy to cisplatin
Objective
  • Primary
    • PFS
    • QoL
  • Secondary
    • Locoregional failure
    • Distant failure
    • OS
    • Safety
    • Locoregional Control
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
HPV positive (+)
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X