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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
NCT01810913 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Atezolizumab
- DRUG Cisplatin
- BIOLOGICAL Cetuximab
- PROCEDURE Biopsy Procedure
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
- Mercy San Juan Medical Center — Carmichael
- UC San Diego Health System - Encinitas — Encinitas
- UC San Diego Moores Cancer Center — La Jolla
- Cedars Sinai Medical Center — Los Angeles
- Memorial Medical Center — Modesto
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- Stanford Cancer Institute Palo Alto — Palo Alto
- Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville
- Sutter Medical Center Sacramento — Sacramento
- University of California Davis Comprehensive Cancer Center — Sacramento
- UCSF Medical Center-Mount Zion — San Francisco
- UCSF Medical Center-Mission Bay — San Francisco
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
- The Kirklin Clinic at Acton Road — Birmingham
Arizona
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2013-03-22 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01810913
The ClinicalTrials.gov registry entry for NCT01810913 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 613 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01810913 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01810913 about?
NCT01810913 is a clinical study titled "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". 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...
What is the current status of trial NCT01810913?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 613 participants. The study started on 2013-03-22. Estimated completion is 2027-01-01.
What conditions does trial NCT01810913 study?
This clinical trial studies the following conditions: Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, 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 IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01810913?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Atezolizumab (DRUG), Cisplatin (DRUG), Cetuximab (BIOLOGICAL), Biopsy Procedure (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01810913?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01810913 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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