454 Participants NeededMy employer runs this trial

Radiation + Cetuximab vs Chemotherapy for Head and Neck Cancer

Recruiting at 62 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: NRG Oncology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

LK

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

* Local evaluation of p16 status is required for all oropharynx patients prior to registration
My cancer is stage III or IVB and has not spread to distant organs.
I have a confirmed, untreated squamous cell carcinoma in my throat or mouth that hasn't been removed.
See 7 more

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

Group I: Arm 1 (IMRT, cetuximab)Experimental Treatment7 Interventions
Group II: Arm 2 (IMRT, carboplatin, paclitaxel)Active Control8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+