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Trial to assess high-dose, MRI-guided radiation therapy for pancreatic cancer
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Researchers are launching a multi-institutional trial to test the effectiveness of precise, higher dose, MRI-guided radiation therapy to treat pancreatic cancer.
“High-definition MRI and daily treatment plan adaptation allow us to deliver ablative radiation doses safely to [patients with pancreatic cancer] for the first time,” Parag Parikh, MD, director of gastrointestinal radiation oncology and MRI-guided radiation therapy at Henry Ford Cancer Institute, said in a press release. “Through the trial, we will build upon the promising experience from other cancer institutions by further exploring MRI-guided therapy’s impact on associated toxicity, local control and patient outcomes in pancreatic cancer at multiple institutions around the world.”
The 5-year, prospective SMART trial — the acronym for which stands for Stereotactic MRI-guided On-table Adaptive Radiation Therapy — will enroll 133 patients with borderline resectable or inoperable locally advanced pancreatic cancer.
Study participants will received radiation at a dose of 50 Gy in five fractions. Real-time MRI will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.
The trial opened at Henry Ford Cancer Institute and is being led by Parikh and Percy Lee, MD, radiation oncologist at UCLA Medical Center.
HemOnc Today spoke with Parikh about the need for more effective treatments for these patients, prior investigations of this modality for pancreatic cancer, the rationale for the SMART trial, and potential implications if this approach is determined to be effective and safe.
Question: Can you characterize the need for more effective treatments for these patients?
Answer: Patients with inoperable pancreatic cancer have a poor prognosis. Median survival for these patients often is far less than 2 years. They are treated with chemotherapy. Radiation has been thought to help with local control but not thought to add time to this very short survival.
Q: What prior investigations have been conducted of this modality for pancreatic cancer?
A: The most recent study, LAP07, was published in 2016. Researchers initially gave patients chemotherapy. Of those who did not have metastatic spread, half went on to receive more chemotherapy and the other half received standard radiation therapy once daily — with no special targeting — for 5.5 weeks. The researchers found that standard radiation therapy did not improve survival of these patients, showing there is a need for improved radiation.
Q: What is the rationale for the SMART trial?
A: The radiotherapy used in the trial is MRI-guided. The adaptive part means that we can use the MRI to identify structures that are damaged with radiation, such as the stomach and duodenum, and change the radiation plan to avoid this on a daily basis. This is how we can get the radiation therapy in at a much higher dose over a shorter period of time than ever before.
Q: Can you provide an overview of the trial?
A: This is a prospective, phase 2, multi-institutional study looking at 133 patients who have borderline resectable or advanced pancreatic cancer and stable disease after 3 months of chemotherapy. All patients will be treated with the MRI-guided adaptive radiation therapy. They will be followed every 3 months for toxicities and outcomes. The primary endpoint is safety at 90 days; secondary endpoints are DFS and OS. In our retrospective experience with this type of treatment, we found an improvement in 2-year survival of around 70%, which is much higher than has ever been seen in this population.
Q: What is the anticipated timeline for results?
A: The study opened at Henry Ford Cancer Institute in December and we expect it to be open across six sites by the end of this summer. We hope to complete accrual within the next 2 years. Results are expected to become available within 2 years of that date.
Q: What are the potential implications if this approach is determined to be effective and safe?
A: This is the first prospective study that has used ablative doses of radiation. Ablative doses are used to cure other cancers, such as early-stage lung cancer. If this approach is safe and effective, it may become a standard of care in pancreatic cancer or involved in a study comparing it to chemotherapy for use in this cancer type. – by Jennifer Southall
Reference:
Hammel P, et al. JAMA. 2016;doi:10.1001/jama.2016.4324.
For more information:
Parag Parikh , MD, can be reached at Henry Ford Cancer Institute, 2799 W. Grand Blvd., Detroit, MI 48202; email:pparikh2@hfhs.org.
Disclosure: Parikh reports research funding from ViewRay Inc.