Michael Lowe and Michael Turgeon accepted into ACCR/ASCO Clinical Trials Workshop

June 2020

The clinical trial proposals of Michael Lowe, MD, surgical oncologist and director of extramural studies for the Emory general surgery residency, and Michael Turgeon, MD, general surgery resident and Katz Foundation Research Fellow, were accepted for the prestigious American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) Clinical Cancer Research Workshop.

Intended for clinical fellows, junior faculty, and early career clinical scientists, this intensive workshop covers the essentials of effective clinical trial designs of therapeutic interventions in the treatment of cancer, and guides participants through the process of developing concept sheets for their trial protocols, crafting the design of their trials, and writing their final protocols under the mentorship of national leaders in oncology. Originally scheduled for July 25-31 in Vail, CO, the workshop was canceled due to COVID-19, but Dr. Lowe and Dr. Turgeon will engage in virtual mentoring to finalize their protocols.

Dr. Lowe's proposal is a randomized, controlled trial that seeks to evaluate the impact of surgery in patients who would typically only be offered medical therapy. Historically, highly selected patients that undergo surgery for metastatic melanoma consistently have improved survival compared to patients who are considered unable to have surgery, though there are no prospective studies confirming the benefit of upfront surgery.

To determine if the addition of surgery to medical therapy improves survival, Dr. Lowe's international multi-center trial will randomize patients with resectable stage IV melanoma into two groups: one that will have surgery followed by systemic therapy, and another that will only receive systemic therapy without surgery.

Dr. Turgeon's multi-institutional proposal was conceived with his mentors and Emory surgical oncologists Shishir Maithel, MD, and Maria Russell, MD, and is a Phase II, randomized control trial to determine the ideal time for hepatitis C virus (HCV) treatment as it relates to liver transplantation for hepatocellular carcinoma (HCC).

Conflicting retrospective data has resulted in significant variability in practice patterns regarding the timing of direct-acting antiviral (DAA) administration for treating HCV in HCC liver transplantation patients. Providing DAAs before liver transplantation to treat patients' HCV while they are on the waitlist has been shown to halt the progression of liver disease, while the benefits of administering DAAs after liver transplantation include maintaining eligibility for HCV-positive donor livers, improving recurrence-free survival for HCC, and increasing rates of sustained virologic response.

The overriding aim of Dr. Turgeon's proposal is to formally evaluate the ideal time to administer DAAs to inform standardized treatment algorithms.