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Coin of the Realm

Duke Clinical Research Institute/ACOSOG, 2400 Pratt Street, Terrace Level Room 0311, Durham, North Carolina 27705

Correspondence: Address correspondence and reprint requests to: David M. Ota, MD; E-mail: david.ota{at}duke.edu.

We need your help for patient enrollment. The American College of Surgeons Oncology Group (ACOSOG) is an National Cancer Institute–funded cooperative group and develops and conducts multi-institutional clinical trials relevant to surgeons. AC-OSOG is the only cooperative group whose primary focus is the surgical management of patients with malignant solid tumors. The scientific themes of ACOSOG trials are (1) to conduct studies that evaluate new surgical or nonsurgical interventions in patients with malignant solid tumors, (2) to study patients with early-stage disease and to design neoadjuvant or adjuvant therapeutic trials, and (3) to conduct trials that define the optimal management of patients with metastases confined to a region or organ. The legacy trials—the Z10 breast cancer sentinel lymph node (SLN) and bone marrow trial (closed), the Z40 non–small-cell lung cancer (NSCLC) lymph node and bone marrow trial (closed), and the Z360 oral cavity cancer SLN trial (closed)—are examples of micrometastasis investigations in early-stage disease. Surgical intervention trials include Z30 NSCLC lymphadenectomy (closed), Z11 breast cancer SLN (closed), and Z4032 NSCLC wedge resection versus wedge resection plus brachytherapy (open). The Z9001 phase III gastrointestinal stromal tumor adjuvant trial (open) and the Z1031 phase III pre-operative aromatase inhibitor therapy for breast cancer (open) are examples of adjuvant and neoadjuvant trials that are very relevant to surgeons. Several ACOSOG trials (Z10, Z30, Z40, Z50, Z60, Z4031, Z5031, and Z360) successfully completed patient accrual and demonstrate that surgeons can conduct and complete multicenter trials at several disease sites. Data from the legacy trials are starting to mature, and publications are forthcoming. These legacy trials will spawn successor trials now in development.

ACOSOG has reached a critical moment going into our National Cancer Institute grant renewal. Patient accrual into clinical trials is the ‘‘coin of the realm’’ and is crucial to the success of the group. By September 30, 2006, we had benchmarked the following accrual targets. For Z1031 and Z4032, the expected accrual rate for Z1031 (breast) is 10 patients per month, and for Z4032 (thoracic) it is 5 patients per month. We expect to enroll 25 patients to Z6041 (rectal) and 20 patients to E5202 (colon) by the end of this September. If ACOSOG does not meet these targets, the group is at risk for losing its National Cancer Institute grant and its existence. ACOSOG is dedicated to cancer trials that are relevant to surgeons and has expended considerable resources to educate surgeons regarding the regulations and conduct of clinical trials. It is critical that we now demonstrate accrual to these trials. Therefore, we urge you to consider the active open trials listed on the ACOSOG Web site (http://www.acosog.org). The group is now focused on breast, thoracic, and gastrointestinal malignancies. The open trials are relevant to both academic and community-oriented surgeons. In fact, 60% of ACOSOG enrollment has come from private-practicing surgeons who have incorporated clinical research into their office practice. We call on all surgeons who have previously enrolled onto ACOSOG trials to evaluate their patients for our current open trials. For those who wish to become members, the ACOSOG Web site offers simple instructions on how to become a member. For information and assistance, you can contact Helen Harbett, membership coordinator, at 919-668-8836 (harbet001{at}notes.duke.edu), Dr. David Ota (david.ota{at}duke.edu), or Dr. Heidi Nelson (nelsonh{at}mayo.edu). ACOSOG needs your involvement. More to follow.

Received for publication April 19, 2006. Accepted for publication April 19, 2006.

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