Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Jason Chan (ucsf)
Headshot of Jason Chan
Jason Chan

Description

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.

Official 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

Details

Keywords

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, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Cisplatin, Docetaxel, Cetuximab, Atezolizumab, Immunological Antineoplastic Agents, Antibodies, Immunoglobulins, Monoclonal Antibodies, Biopsy, Biospecimen Collection, Computed Tomography, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Quality-of-Life Assessment, IMRT, cisplatin, IMRT, docetaxel, IMRT, docetaxel, cetuximab, IMRT, cisplatin, atezolizumab

Eligibility

Locations

Lead Scientist at University of California Health

  • Jason Chan (ucsf)
    Dr. Jason Chan is a radiation oncologist who specializes in the treatment of head and neck, skull base, cutaneous, and thoracic malignancies. Dr. Chan received his undergraduate and medical degrees from Brown University. He completed his Internal Medicine internship at Kaiser Permanente San Francisco and his residency in Radiation Oncology at UCSF.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT01810913
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 613 study participants
Last Updated