Name of the Trial
Phase III Randomized Study of Concurrent Accelerated Fractionated Radiotherapy and Cisplatin with versus without Cetuximab in Patients with Stage III or IV Squamous Cell Carcinoma of the Oropharynx, Hypopharynx, or Larynx (RTOG-0522). See the protocol summary at http://cancer.gov/clinicaltrials/RTOG-0522.

Principal Investigator
Dr. K. Kian Ang, Radiation Therapy Oncology Group

Why This Trial Is Important
Recent clinical trials have shown that treating locally advanced head and neck cancer with combined chemotherapy and radiation therapy helps patients live longer than if they are treated with radiotherapy alone.

This trial will enroll patients with locally advanced squamous cell carcinoma of the larynx, oropharynx, or hypopharynx. "Locally advanced" means that the cancer has spread to nearby tissues or lymph nodes but not elsewhere. All patients will be treated with radiotherapy and the chemotherapy drug cisplatin. In addition, half of the patients will be treated with a monoclonal antibody called cetuximab.

Cetuximab targets a protein called epidermal growth factor receptor (EGFR), which is found in excess amounts on the surface of many cancer cells. Blocking the activity of EGFR may inhibit a tumor's ability to grow. In a previous trial, adding cetuximab to radiotherapy significantly improved the survival of patients with locally advanced head and neck cancer (see related article). Researchers want to know if adding cetuximab to radiotherapy and cisplatin treatment will help patients live longer without their cancer recurring.

"Earlier trials have proven that combining radiation with either cisplatin or cetuximab decreases the likelihood of recurrence," said Dr. Ang. "With this trial, we hope to see if combining radiation with both agents further improves disease-free survival."

Who Can Join This Trial
Researchers will recruit 720 patients aged 18 or over with stage III or stage IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx with no distant metastases. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/RTOG-0522. This trial is eligible for special Medicare coverage.

Study Site and Contact Information
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/RTOG-0522 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.