Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator
Andy Trotti, MD
Status
Closed to Accrual & Treatment
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.