The University of Louisville has enrolled the first patient in AngioDynamics’ NanoKnife Irreversible Electroporation (IRE) “Data IRE Cancer Treatment” clinical study (DIRECT). The DIRECT Study supports a proposed expanded use of the NanoKnife System in the treatment of stage III pancreatic cancer.
“We are pleased to be the first enrolling site. The DIRECT Study represents an important milestone in the standardization of care for patients with stage III pancreatic cancer,” said Robert C.G. Martin, MD, co-principal investigator of the DIRECT Study; director, Division of Surgical Oncology; professor of surgery, University of Louisville and surgical oncologist with UofL Physicians – Surgical Oncology.
“Our goal is to generate important data that should standardize and optimize the use of IRE in the treatment of locally-advanced pancreatic cancer, significantly improving outcomes for patients with this late-stage diagnosis,” Martin said.
Annually, there are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States. Deaths from pancreatic cancer are projected to increase dramatically in the coming years, with a trajectory of becoming the second leading cause of cancer-related deaths before 2030.
The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs. Less than 20% of patients are candidates for surgical resection at time of diagnosis.
Approximately 35 to 40% of patients will initially present with stage III and 45 to 55% with metastatic disease. Regardless of the stage of pancreatic cancer, it is one of the least survivable cancers, and survival rates have not improved substantially for more than 40 years. For all stages combined, the five-year relative survival rate is 8% and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3%.
The DIRECT study continues the research of Martin and other health care providers at UofL that has helped lead to results that have tripled the overall survival in stage III pancreatic cancer.
AngioDynamics’ DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to health care professionals, support a regulatory indication for the treatment of stage III pancreatic cancer and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the U.S. Food and Drug Administration, which allows participating sites to obtain coverage for procedures performed, in addition to related routine costs.
The DIRECT Study includes a randomized controlled trial at up to 15 sites, as well as a real-world evidence, next generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary goal of the study is overall survival.
As part of the DIRECT Study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants. The online platform provides patients and their families with information about pancreatic cancer and details about the study. It also features a physician locator to help prospective participants and referring health care professionals identify clinical study locations.