Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin
Eligible age
18+ yrs
Accepts
All genders
Locations
27 states
Healthy volunteers
No
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About this study
This phase III trial compares cetuximab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetuximab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with advanced head and neck cancer who are unable to receive cisplatin.
Sponsor: NRG Oncology
You may qualify if…
- ✓ Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity
- ✓ Local evaluation of p16 status is required for all oropharynx patients prior to registration
- ✓ Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration
- ✓ Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:
- ✓ Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 9th edition stage III-IVB
- ✓ Eligible Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:
- ✓ AJCC 9th Edition TNM: T3 N0 or T1-3 N1 M0; AJCC 9th Edition Stage: III
- ✓ AJCC 9th Edition TNM: T1-3 N2 or T4a N0-N2 M0; AJCC 9th Edition Stage: IVA
Where it's recruiting
Birmingham
Anaheim · Baldwin Park · Bellflower · Beverly Hills …
Newark · Wilmington
Bay Pines
Atlanta
Bloomington · Canton · Carthage · Chicago …
Ames · Cedar Rapids · Clive · Des Moines …
Kansas City · Lawrence · Overland Park · Salina …
Lexington · Louisville
Brewer
Ann Arbor · Brighton · Canton · Chelsea …
Bemidji
Source: ClinicalTrials.gov · NCT07441681 · last updated 2026-10-27