RTOG-1016
Terminated
Protocol Information
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator
Andy Trotti
Status
Terminated
Open to Accrual
December 9, 2013
Closed to Accrual
December 9, 2013
Closed to Accrual
July 31, 2014
Closed to Accrual & Treatment
October 26, 2015
Closed to Accrual & Treatment
October 21, 2014
Terminated
September 4, 2025
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
849
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.