Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer

Background: Historically, fewer than 5% of cancer patients enroll in clinical trials and lack of physician participation is a contributing factor. In 1999, the American College of Surgeons Oncology Group (ACOSOG) conducted a multicenter breast cancer trial evaluating the prognostic value of sentinel lymph node (SLN) and bone marrow micrometastases. This report elucidates factors influencing patient accrual. Methods: Demographics of investigators (N = 198) and their success in accruing patients (N = 5327) were reviewed. ACOSOG Breast Committee members (N = 1136) were surveyed to identify factors influencing participation. Results: Surgeons from 126 institutions participated in Z0010 (academic [48%], teaching-affiliated [20%], and community [29%] practices), and 28% of surgeons accrued 75% of the subjects. Twenty-four percent of surgeons accrued 75% of minority patients. Female surgeons accrued 24% of patients and accounted for 30% of investigators. On survey, 16% of respondents reported no prior experience with clinical trials and a number of factors were identified that influenced participation. Conclusions: ACOSOG successfully accrued 5327 patients to a SLN trial with surgeon participation from all practice settings. However, significant barriers to participation remain.