RTOG-1216

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

Principal Investigator

Paul Harari, MD

Status

Open to Accrual

Disease Site

Head and Neck [HN]

Head and Neck

Phase

II/III

Developmental Therapeutics

No

Primary Objective

Phase II (completed): To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin

Phase III:

1. To determine if the combination of docetaxel-cetuximab and IMRT is superior in terms of overall survival (OS) compared to standard cisplatin andIMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC
2. To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvanttreatment of pathologic high risk, HPV-negative HNSCC.

Patient Population

Patients with pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx (p16 negative), larynx, or hypopharynx. Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink or tumor in a final separately submitted margin)

Target Accrual

684