NRG-HN002

Terminated

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

Principal Investigator

Sue S. Yom

Status

Terminated

Open to Accrual

October 22, 2014

Open to Accrual

October 27, 2014

Closed to Accrual

February 7, 2017

Closed to Accrual & Treatment

April 4, 2017

Terminated

September 4, 2025


Disease Site

Head and Neck [HN] Head and Neck

Phase

II

Developmental Therapeutics

No

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

Protocol Documents

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


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.