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In spite of precise, effective treatment of head and neck squamous cell cancer, half of patients will experience recurrence — their cancer will return in the same area as the original cancer. That can be life-threatening.

“When this cancer comes back after surgery and/or radiation therapy, the cancer can affect speech and swallowing, invade blood vessels, block the airway and be detrimental for a patient’s overall quality of life,” said Musaddiq Awan, MD, radiation oncologist and MCW faculty member.

To improve the outlook, Dr. Awan has been awarded a grant from the National Institutes of Health to study the use of magnetic resonance (MR) image-guided radiation therapy coupled with immunotherapy. Dr. Awan is principal investigator of this phase I clinical trial, which is available only through the Froedtert & the Medical College of Wisconsin Cancer Network.

“The goal of the trial, if it is ultimately successful, is to offer the therapy to all head and neck cancer patients to improve cancer control and survival,” Dr. Awan said. “As a phase I trial, the new regimen is being tested with patients who cannot tolerate standard-of-care treatment or for whom the cancer has spread and standard-of-care treatment is not appropriate.”

The trial builds on a radiation therapy method called hypofractionation that has been effective for other cancers, including lung cancer. It involves reducing the total radiation therapy time while intensifying the dose.

“The study has two components,” Dr. Awan said. “The first involves giving a larger dose of radiation and shortening the course of treatment from six or seven weeks to three weeks. In the second component, we reduce toxicity by adapting the radiation exactly to the tumor’s margins as it shrinks during treatment.”

Researchers will use the Unity MR-linac, which combines MR imaging with a linear accelerator. This technology allows doctors to capture daily images of the tumor in real time during treatment.

“Each week, we adjust the radiation pattern to target the tumor more precisely with a greater radiation dose,” Dr. Awan said. “MR-linac allows us to tailor treatment to how the tumor is responding to radiation therapy.”

The phase I trial will test safety by finding the maximum tolerated — and safe — radiation dose and identifying side effects. With the trial’s multidisciplinary approach, participants will also receive a single dose of immunotherapy once a month during radiation therapy and up to one year afterward. Researchers expect the immunotherapy/radiation therapy combination to enhance treatment effectiveness.

“We see patients go through very difficult treatment for head and neck cancer that can affect their ability to eat, swallow and speak,” Dr. Awan said. “By doing this trial, we hope to cure more people, while better maintaining quality of life.”

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