Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator
Andy Trotti, MD
Status
Closed to Accrual
Date Opened To Accrual
June 09 2011
Date Closed to Accrual
July 31 2014
Disease Site
Head and Neck [HN]
Head and Neck
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival
Closed to both Step 1 and Step 2 Registration.
Note: If your site is in possession of an RTOG 1016 study iPad, contact Robert Pickard at rtog1016@osumc.edu or 1-614-292-0875 to make arrangements for the return of the iPad.
The quality of life (QOL) component met its accrual objective (400 patients) and closed to accrual on 2/28/13.
Patient Population
Squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); stage T1-2, N2a-3, or T3-4 any N; patient tumor must be p16 positive
Target Accrual
834
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.