Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Summary

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Conditions

• Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
• Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions

DRUG

Atezolizumab

Given IV

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood

BIOLOGICAL

Cetuximab

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Docetaxel

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Paul M Harari · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-22

Primary Completion

2027-01-01

Completion

2027-01-01

Countries

• United States
• Canada
• Hong Kong

Study Locations