RTOG-1016

Terminated

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Protocol Information

Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants

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.


Patient Study Webpage

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