Guided Radiation Technique Will Be Studied in Phase 3 Pancreatic Cancer Trial

A clinical trial will determine if chemotherapy plus 5-fraction MRIdian SMART will improve survival over chemotherapy alone in patients with locally advanced pancreatic cancer.

A phase 3 clinical trial recently launched and will compare a combination of chemotherapy and 5-fraction MRIdian SMART (stereotactic MR-guided adaptive radiotherapy) to chemotherapy treatment (the current standard of care) for patients with locally advanced pancreatic cancer.

In particular, 5-fraction MRIdian SMART uses MRI technology to locate and track cancerous cells, and deliver radiation to them, while sparing surrounding healthy tissue, according to a press release from ViewRay, Inc., the manufacturer of 5-fraction MRIdian SMART. The clinical trial, which is known as LAP-ABLATE, will determine if patients who receive this treatment after chemotherapy live longer than those who only undergo chemotherapy.

Previous studies of non-ablative radiotherapy for patients with locally advanced pancreatic cancer showed that the treatments lead to toxicity in the stomach and bowel loops, which led to severe side effects such as pain, bleeding or bowel obstruction.

"While prior studies of chemotherapy plus non-ablative radiation have not shown an improvement over chemotherapy alone for patients with (locally advanced pancreatic cancer), we believe MRIdian's advanced capabilities overcome the many limitations of other radiation treatment modalities,” said Dr. Michael D. Chuong, lead investigator of LAP-ABLATE and medical director of radiation oncology at Miami Cancer Institute, in the release. “Ablative doses with MRIdian SMART can provide pancreatic cancer patients a clinically meaningful improvement in long-term survival while maintaining an excellent quality of life and rarely causing significant side effects.”

Researchers conducting the LAP-ABLATE trial anticipate enrolling 267 patients, with two-thirds of patients receiving the chemotherapy/5-fraction MRIdian SMART therapy, and one-third receiving chemotherapy alone, according to the release. Participants will be randomly assigned to either treatment group.

To be eligible to participate in the trial, patients with locally advanced pancreatic cancer must have had a minimum of four months from the start of chemotherapy to their last dose; have undergone eight or more of modified FOLFIRINOX (including oxaliplatin, leucovorin, irinotecan and fluorouracil) or 12 doses of gemcitabine/nab-paclitaxel, and do not have radiographic evidence of local or distant disease progression. Other eligibility criteria include having no major impacts on daily life function, and adequate bone marrow and organ function, according to the trial’s ClinicalTrials.gov listing.

The main goal of the trial is to see which treatment group has a longer overall survival (time from treatment until death of any cause) at the two-year mark. Researchers will also look at progression-free survival (time from treatment until disease worsens), local and regional disease control, length of time patients live without distant metastases, quality of life and side effects.

"Despite major advances in other oncology indications, treatment options for pancreatic cancer remain severely limited, including for patients with locally advanced disease," said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network (PanCAN), in the release. "At PanCAN, we support patient involvement in clinical trials as a way to gain access to some of the best treatment options and most cutting-edge approaches. We're looking forward to the results of the LAP-ABLATE trial and the opportunity to validate a potential breakthrough therapy for this group of patients."


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