RTOG 1016.

Trial name or title	'Phase III trial of radiotherapy plus cetuximab versus chemoradiotherapy in HPV‐associated oropharynx cancer (RTOG‐1016)'
Methods	Interventional, multicentre, phase III trial, randomised, open‐label
Participants	706 adult patients with early or late‐stage oropharyngeal carcinoma. HPV status ascertained at baseline by both p16 immunohistochemistry and HPV16 in situ hybridisation. Patients are stratified according to T stage (T1‐2 versus T 3‐4), N stage (N0‐2a versus N2b‐3), Zubrod performance status (0 versus 1) and smoking history (≤ 10 pack‐years versus > 10 pack‐years). Patients are randomised to 1 of 2 treatment arms
Interventions	Experimental group: 1 week prior to radiotherapy, patients receive cetuximab IV over 2 hours (400 mg/m2). Patients then receive cetuximab IV over 1 hour once weekly (250 mg/m2) for 7 weeks. Patients undergo IMRT once daily on days 1 to 4 and twice daily on day 5 weekly for 6 weeks (70Gy 35 fractions). Control group: patients undergo IMRT as above and also receive cisplatin (100 mg/m2) IV over 1 to 2 hours on days 1 and 22
Outcomes	Primary: 5‐year overall survival Secondary: progression‐free survival, local‐regional failure, distant metastasis, acute toxicities (CTCAE 2009) and overall toxicity burden at end of treatment and at 1, 3 and 6 months after completion of treatment; late toxicities at 1, 2 and 5 years
Starting date	June 2011
Contact information	andy.trotti@moffitt.org
Notes	Primary data collection due for completion in June 2020