Sponsor: NRG
Sponsor Study ID: RTOG 1216
Study Title: Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
CTO #: 103994
NCT Number: NCT01810913
Phase: II/III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lip, Oral Cavity and Pharynx
Study Objectives: To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. To determine if the combination of docetaxel-cetuximab and IMRT is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC. To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV- negative HNSCC.