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

Description
About 675 people will take part in this study nationally and about 25 will be enrolled at this
institution. At the beginning of the study, about 200 subjects will be randomized to one of 3
treatments: a standard treatment or one of 2 experimental treatments. If the second part
of the study proceeds, about 475 subjects will be randomized to one of 2 treatments: a
standard treatment and one of the experimental treatments from the first part of the
study.

Objective
First part of the study

The purpose of the this part of this study is to find out what effects, good and/or bad,
one of the following treatments has on your type of cancer. In this part of the study, you
will receive one of the following treatments:

• Standard treatment: radiation therapy and cisplatin

• Experimental treatment: radiation therapy and docetaxel

• Experimental treatment: radiation therapy, docetaxel, and cetuximab



Second part of the study

This part of the study will proceed only if certain results are achieved in the first
part of the study.
The purpose of this part of this study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) with one of the experimental treatments chosen from the first part of the study (either radiation therapy and docetaxel
or radiation therapy, cetuximab, and docetaxel) to find out which is better. In this part of the study, you will get either the standard treatment or the experimental treatment.



If you agree to take part in this study, you will take part in either the first OR the second
part, not both.

Treatment Cisplatin and docetaxel are standard chemotherapy drugs. The dose and schedule of
docetaxel given in this part of the study is considered experimental.
Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that
affects cancer growth and many other functions.

Key Eligibility
Proven diagnosis of head and neck squamous cell carcinoma involving the oral cavity, oropharynx (p16 negative), larynx or hypopharynx within 49 days of registration.

Patient must have undergone gross total surgical resection of high-risk oral cavity, oropharynx
(p16 negative), larynx, or hypopharynx within 49 days prior to registration.

Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal
extension or invasive cancer seen within 3 mm of the primary tumor resection margins.

Patient must have stage III or IV head and neck squamous cell carcinoma, including no distant metastases.

Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of
patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid
carcinoma, who are eligible.

Patients who have had prior systemic chemotherapy or anti-EGF therapy for head and neck squamous cell carcinoma are not eligible.

Patients who have had prior radiotherapy that would result in overlap of radiation therapy fields are not eligible.

Applicable Disease Sites
Head and Neck

Participating Institutions
Johnson Creek, UW Cancer Center; UW Health Carbone Cancer Center Rockford; UW Health Eastpark Medical Center; UW Health University Hospital