Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin

Program Overview

This clinical trial is comparing two treatment options for patients with head and neck cancer who cannot receive the standard drug cisplatin. The study is testing whether radiation therapy combined with cetuximab, a medication that targets cancer cells, is as effective as radiation combined with chemotherapy drugs carboplatin and paclitaxel. The goal is to find out which combination works better at controlling the cancer and improving patient outcomes.

Description

The main goal of this study is to see if radiation therapy combined with carboplatin and paclitaxel improves the time patients live without the cancer getting worse, compared to radiation with cetuximab. Researchers will also look at overall survival rates, safety, and side effects of the treatments. They will study how the treatments affect eating and speaking abilities and track where and how the cancer might return.

Participants will be randomly assigned to one of two groups:

• Group 1: Will receive radiation therapy five days a week for 35 treatments, along with cetuximab given through an IV. This will continue for seven cycles, each lasting seven days, unless the cancer progresses or side effects become too severe.

• Group 2: Will receive the same radiation schedule, but with carboplatin and paclitaxel given through an IV. This will also continue for seven cycles, each lasting seven days, unless the cancer progresses or side effects become too severe.

Throughout the study, participants will have CT and PET scans and provide blood samples to monitor their health and the cancer's response to treatment. After completing the treatment, participants will have follow-up visits at 30 days, then at 4, 6, 12, 18, 24, 30, and 36 months, and annually after that.

Eligibility Criteria

Locations