PresentationPatterns 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
Section snippets
Methods
The primary objectives of the Z0010 trial were (1) to estimate the prevalence of and evaluate the prognostic significance of sentinel node micrometastases detected by immunohistochemistry (IHC); (2) to estimate the prevalence of and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry (ICC); and (3) to determine the hazard rate for regional recurrence in women whose sentinel nodes were negative by hematoxylin and eosin (H&E) staining in women with
Results
Surgeons from 126 institutions located in 37 states of the United States, and in Ireland and Australia, participated in Z0010. These surgeons were located at academic (48.4%), teaching-affiliated (19.8%), and community (28.6%) practices. Overall, approximately 50% of Z0010 investigators were at community or teaching-affiliated institutions compared with 41% of all ACOSOG investigators (chi-square = 6.1838, P = .0129). Surgeons accrued a median of 12 patients to study (range 1 to 290). The 10
Conclusions
The ACOSOG Z0010 trial was successful in attracting a large cadre of surgeons for study participation despite a stringent credentials documentation requirement (≥20 cases of SLNB followed by ALND). This is in contrast to the National Surgical Adjuvant Breast and Bowel Project (NSABP) B32 trial that allowed surgeon participation after a study sponsored training with only five cases of SLND followed by ALND [1]. ACOSOG investigators were successful in completing accrual to the Z0010 trial with
References (2)
- et al.
A report on accrual rates for elderly and minority-ethnicity cancer patients to clinical trials of the American College of Surgeons Oncology Group
J Am Coll Surg
(2004) - et al.
Pre-randomization surgical training for the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 Triala randomized phase III clinical trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer
Ann Surg
(2005)