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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 ³.

Principal Investigator

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

Dr. K. Kian Ang Principal Investigator

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 ⁴). 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 ⁵. This trial is eligible for special Medicare coverage ⁶.

Study Site and Contact Information

Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites ⁷ 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.

Glossary Terms

A monoclonal antibody used to treat certain types of head and neck cancer, and colorectal cancer that has spread to other parts of the body. It is also being studied in the treatment of other types of cancer. Monoclonal antibodies are made in the laboratory and can locate and bind to cancer cells. Cetuximab binds to the epidermal growth factor receptor (EGFR), which is found on the surface of some types of cancer cells. Also called Erbitux.

Treatment with drugs that kill cancer cells.

A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent. Also called Platinol.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

The bottom part of the throat. Cancer of the hypopharynx is also known as hypopharyngeal cancer.

The area of the throat containing the vocal cords and used for breathing, swallowing, and talking. Also called voice box.

The part of the throat at the back of the mouth behind the oral cavity. It includes the back third of the tongue, the soft palate, the side and back walls of the throat, and the tonsils.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.