Radiation + Cetuximab vs Chemotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial compares cetuxumab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer 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 cetxiumab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with head and neck cancer who are unable to receive cisplatin.
Who Is on the Research Team?
Loren K Mell
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with certain types of head and neck cancers (like larynx, hypopharynx, oropharynx, or oral cavity) that have not been treated before and cannot be removed by surgery. Participants must not be able to receive cisplatin due to health reasons.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cetuximab
- Intensity-Modulated Radiation Therapy
- Paclitaxel
Trial Overview
The study compares two treatments: one group gets radiation plus cetuximab (a targeted therapy), while the other gets radiation plus chemotherapy drugs carboplatin and paclitaxel. The goal is to see which combination works better for people who can't take cisplatin.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergo IMRT 5 days per week for 35 treatments. Starting within 7 days prior to radiation, patients receive a loading dose of cetuximab IV and then concurrently with radiation on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan on study and blood sample collection throughout the study. Patients may undergo PET scan or MRI during screening.
Patients undergo IMRT 5 days per week for 35 treatments. Starting on day 1 of radiation, patients receive concurrent carboplatin IV and paclitaxel on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan on study and blood sample collection throughout the study. Patients may undergo PET scan or MRI during screening.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.