NRG Oncology
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.
PRIMARY OBJECTIVE: I. To determine whether radiation therapy (RT) and concurrent carboplatin and paclitaxel (RT + carboplatin and paclitaxel \[CP\]) improves progression-free survival (PFS) compared to RT with concurrent cetuximab (RT + cetuximab \[Cetux\]) in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between RT+CP versus (vs.) RT + Cetux. II. To compare PFS and OS by study arm within p16-negative and p16-positive subgroups. III. To compare safety and toxicity of RT+CP…
Inclusion Criteria: * 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) 8th edition stage III-IVB * Laryngeal,…
Undergo blood sample collection
Given IV
Given IV
Undergo CT scan
Undergo IMRT
Undergo MRI
Given IV
Undergo PET scan
Ancillary studies