Perioperative Clinical Trials for Pancreatic Cancer in the National Clinical Trials Network

Excerpt

In this issue of Annals of Surgical Oncology, Dr. Wei and colleagues report the final results of the American College of Surgeons Oncology Group (ACOSOG) Z5041 phase II trial of preoperative gemcitabine and erlotinib followed by pancreatoduodenectomy for patients with resectable pancreatic adenocarcinoma (PDAC).1 ACOSOG investigators accrued 114 patients to this study during a 56-month period beginning in 2009. Unfortunately, due to slow accrual, the trial was terminated prematurely in 2013, before enrolling the number of patients required to power formal hypothesis testing. Since 2013, in contrast, the three subsequent studies of patients with localized PDAC that have been conducted within the National Clinical Trials Network (NCTN) of the National Cancer Institute (NCI)—Southwest Oncology Group (SWOG) S1505 and Alliance for Clinical Trials in Oncology A021101 and A021501—together briskly enrolled approximately 300 patients over a total of approximately 72 months, and each closed well ahead of schedule after meeting its accrual goal.2‐4 How can we explain this disparity, and what lessons can we learn from it? …