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Clinical trial of radiation therapy offers complete treatment in fewer visits

Diagnosed with invasive ductal carcinoma, one of the most common types and earliest stages of breast cancer, Michele, a grandmother and full-time caregiver to her husband, was determined to beat the illness with as little interruption as possible.

“I am never sick, so this was a shock for me,” she said.

Michele And George
Michele pictured with her husband, George.

She welcomed news that she qualified for a clinical study at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis. Guided by magnetic resonance imaging, or MRI, the therapy called for Michele to receive one treatment daily for only three days. Under the care of Imran Zoberi, MD, a Washington University professor of radiation oncology and the study’s designer, Michele was able to continue her regular routine with just a few interruptions — and is now cancer-free.

The clinical trial was designed to deliver and test a common approach — surgery to remove the cancerous cells, followed by radiation therapy to reduce the chance of recurrence — but in a shorter period. The goal, Zoberi said, is to deliver the best outcome possible with the fewest number of patient visits.

“We’re able to deliver a high dose of radiation therapy in a very accurate and precise manner to breast tissue immediately adjacent to the breast surgery site,” Zoberi said. “The ability to use MRI-guided radiation therapy allows for this to be done safely. “

The treatment typically occurs two to six weeks after surgery, he said.

The clinical trial was based on use of the breakthrough ViewRay MRIdian technology initially used by Washington University physicians at Siteman. Guided by continuous MRI, the radiation therapy system allows physicians to monitor tumors in real time during the treatment. This allows the treatment team to see where the radiation dose is being delivered and to determine if any subtle changes are occurring to the tumor or surrounding tissue. The ability for continuous soft-tissue imaging means a patient’s treatment plan or radiation dose can be adjusted immediately if changes are noted.

The treatment also is matched with the patient’s breathing. If the breast tissue and, potentially, the tumor, shift when the patient takes a breath, the radiation beam stops.

“This way, we’re targeting only the part of the breast we want to treat, not neighboring healthy tissue,” Zoberi said.

The system was developed by a former Washington University medical physicist and initially evaluated by Washington University radiation oncologists at Siteman Cancer Center. The U.S. Food & Drug Administration (FDA) approved the technology for clinical trial use in 2012. Siteman was the first cancer center to use this advanced cancer treatment technology. Well-suited cases include cancers in the abdomen or pelvis, where current imaging doesn’t allow radiation oncologists to see clearly.

“Dr. Zoberi and his team went above and beyond to make sure I felt comfortable,” Michele said. “They offered me music and made sure I understood the process and treatment. It was not scary in any way and there was no pain whatsoever.”

The expedited combination therapy she received isn’t new. Oncologists elsewhere have delivered radiation therapy to breast cancer patients right after surgery. The potential downside to that approach, though, is that surgeons don’t always immediately know if all cancer cells were removed, resulting in a delay while tissue samples are tested. For this reason, Zoberi opted not to deliver radiation therapy in the operating room. He did want to limit the number of times a patient needed to come in, though, so he designed his clinical trial to balance the two interests.

Because the patient receives a full dose of radiation therapy in only three “fractions” — that is, in three sessions — rather than over many days, it’s more convenient for her. For Michele, who lives about 45 minutes outside of St. Louis, fewer visits meant less time away from home and fewer days she had to set up additional care for her husband.

As for Zoberi and the rest of the treatment team, “If I had to have something, they made it a great experience overall,” Michele added.

Editor’s note: Patients are still being recruited for the clinical trial featured in this story, “Evaluation of Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma.” The ClinicalTrials.gov Identifier is NCT03612648. For more information, visit this Siteman page or ClinicalTrials.gov.

Request an appointment here, or by calling Siteman’s Patient Care Coordination Center at 800-600-3606.