NRG-HN002: A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer, NCT02254278

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Principal Investigator/Radiation Oncology

Sue S. Yom, MD, PhD

Primary Objective

To select the arm(s) achieving a 2-year progression-free survival rate of ≥ 85% without unacceptable swallowing toxicity at 1 year

Patient Population

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); patients must have positive immunohistochemical staining for p16, as confirmed by the NRG Oncology Biospecimen Bank, prior to randomization.

Target Accrual

296 patients


Activated October 27, 2014

Protocol Documents

CTSU - Available via the National Cancer Institute Cancer Trials Support Unit (CTSU) website.


Copyright 2017 by NRG Oncology