Phase 3 Trial of Radiotherapy With/Without Cetuximab in Head and Neck Cancer

Title: Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer¹

Study Chair: Mitchell Machtay, MD, University Hospitals Seidman Cancer Center, Cleveland, Ohio

Description: For this randomized phase 3 study ClinicalTrials.gov Identifier: NCT00956007), researchers are attempting to determine whether radiotherapy is more effective with or without cetuximab among patients with locally advanced head and neck cancer.

There are 2 trial arms: in arm 1 patients will receive radiotherapy 5 days a week for 5 weeks; in arm 2 patients will receive the arm 1 therapy plus cetuximab intravenously 5 or more days before radiotherapy and 4 weeks thereafter. Researchers will discontinue treatment in the event of disease progression or unacceptable toxicity.

The primary outcome is overall survival. Secondary outcomes include toxicity, disease-free survival, and loco-regional control.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01311063.

Status: This study is open and recruiting patients as of February 9, 2017.

Cetuximab is epidermal growth factor receptor (EGFR) inhibitor approved by the U.S. Food and Drug Administration for the treatment of colorectal cancer and neck and neck cancer.

Reference

1. Clinicaltrials.gov. A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer. NCT00956007. https://clinicaltrials.gov/ct2/show/NCT01311063. Accessed February 9, 2017.