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.
Leitch
A Marilyn
AM
Department of Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9155, USA. marilyn.leitch@utsouthwestern.edu
Beitsch
Peter D
PD
McCall
Linda M
LM
Posther
Katherine
K
Newman
Lisa A
LA
Herndon
James E
JE
Hunt
Kelly K
KK
Giuliano
Armando E
AE
D001291:Attitude of Health Personnel; D001365:Axilla; D001856:Bone Marrow Examination; D019046:Bone Marrow Neoplasms / Q000175:diagnosis / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008297:Male; D009367:Neoplasm Staging; D018579:Patient Selection; D021701:Sentinel Lymph Node Biopsy