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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Cetuximab — BIOLOGICAL
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT
• Docetaxel — DRUG
  Given IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Mar 22, 2013

Status verified

Apr 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

613 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (IMRT, cisplatin)
  Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
• Experimental: Arm 2 (IMRT, docetaxel)
  Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)
• Experimental: Arm 3 (IMRT, docetaxel, cetuximab)
  Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
• Experimental: Arm 4 (IMRT, cisplatin, atezolizumab)
  Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Primary Outcome Measure

Disease-free survival (Phase II) [ Time Frame: From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years ]

Locations (338)

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