Kathryn Hitchcock, MD, PhD, discusses the rationale for the ongoing phase 3 ERAsur trial investigating total ablative therapy in patients with limited metastatic colorectal cancer and details the methodologies being used in this study.
Kathryn Hitchcock, MD, PhD, radiation oncologist, University of Florida Health, assistant professor, University of Florida, discusses the rationale for the ongoing phase 3 ERAsur trial (NCT05673148) investigating total ablative therapy in patients with limited metastatic colorectal cancer (mCRC) and details the methodologies being used in this study.
Until recently, patients with metastatic CRC would receive chemotherapy and likely continue with that treatment until the end of their lives, Hitchcock begins. However, some patients with metastatic disease could potentially be curable, she says, adding that curative-intent approaches are currently being pursued in patients with metastatic disease who present with only a few metastases. However, there have been no formal, randomized, prospective studies that have looked at approaches such as total ablative therapy within this setting for this patient population, Hitchcock explains.
ERAsur is enrolling patients with histologically confirmed mCRC who do not have microsatellite instability, BRAF V600E mutations, or known peritoneal disease. Patients need to have a primary tumor that have been resected or is resectable, and they are required to have 4 or fewer metastatic sites. Patients are being randomly assigned to total ablative therapy in addition to standard-of-care systemic therapy or standard-of-care systemic therapy alone.
Prior to randomization, all patients will first receive up-front systemic therapy for 4 to 6 months, Hitchcock says. Those who experience disease progression during this time will be removed from trial protocol.Remaining patients will be randomly assigned to 1 of the 2 treatment arms. In the experimental arm, patients will be allowed to receive any combination of local therapies that could benefit them, in the opinion of the treating physician, Hitchcock continues. Notably, patients are permitted to receive additional chemotherapy following localized treatment, Hitchcock says.
Treatment will continue until disease progression, and all patients will be followed until death, Hitchcock adds. Overall survival is the primary end point, and secondary end points include event-free survival, safety, and time to local recurrence. Notably, patients initially assigned to the control arm will be allowed to receive localized treatment following disease progression, Hitchcock concludes.