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DURHAM, N.C. –- People who are diagnosed with invasive cancer of the head and neck are usually given a grim prognosis. Many die within three years of diagnosis.

The standard treatment for advanced head and neck cancer has been to treat patients with surgery and seven weeks of once-daily radiation therapy. But a new study from Duke University Medical Center finds that when patients are treated with a novel combination of intensive, twice-daily radiation therapy and simultaneous chemotherapy, their disease can be controlled much more frequently.

The findings of the phase III clinical trial appear in the June 18 issue of the New England Journal of Medicine. The research was funded in part by the Duke Comprehensive Cancer Center.

"The improvement for these patients was significant enough that this now constitutes our standard of care at Duke," said Dr. David M. Brizel, associate professor of radiation oncology and member of the Duke Comprehensive Cancer Center.

Each year approximately 50,000 people in the United States are diagnosed with cancer of the head or neck, typically the larynx, pharynx, or tongue. Most cases are associated with cigarette or cigar smoking, or chewing tobacco products.

"If the cancer is detected in an early stage, it is very curable with surgery or radiotherapy alone," he said. "But about 70 percent of these cancers are locally advanced, meaning the cancer is large and has invaded surrounding tissues or spread to the lymph nodes in the neck. Most of these patients will die of their disease within three years with conventional treatment. Moreover, surgery is often disfiguring, and patients may have pain and difficulty swallowing from their radiation treatments."

Brizel and his colleagues devised a strategy that involves treating patients with more radiation, but dividing it into smaller doses. Instead of having one treatment per day, all patients had two treatments per day for five to six weeks. At the same time, half of the 116 patients in the study also received cisplatin and 5-fluorouracil, two chemotherapy drugs commonly used to treat head and neck cancer, during the first and sixth weeks of irradiation.

The researchers found the combined treatment was more successful in controlling the cancer and in stopping recurrence of tumors. Sixty-one percent of the combined treatment patients were still disease-free after three years, compared to 41 percent for the intensive radiation therapy alone. However, both groups did much better than the 25 percent to 30 percent survival that would have been expected with standard once-a-day radiation treatment. The researchers found no increased long-term complications from the addition of the chemotherapy to the radiation.

"We are encouraged by these results," Brizel added. "However, it is important to remember that many patients still die from this disease. We are continuing to try to improve our treatment strategies to help more patients live longer, fuller lives."