Physicians seeking to enroll patients in NCI-sponsored Cooperative Group phase III adult treatment trials have improved access to these studies through the assistance of the Cancer Trials Support Unit (CTSU).

CTSU is an NCI program launched in October 1999 to provide clinicians across the United States and Canada with improved access to cancer treatment trials. The program was initiated following a systematic review of the clinical trials program at the time and led to the Board of Scientific Advisors approving the CTSU as a pilot project. Over the ensuing years, CTSU has become an integral part of the Cooperative Group system that is responsible for conducting most of NCI's phase III treatment trials.

CTSU recently underwent a competitive renewal. The original contractor, Westat, Inc., along with its subcontractor, the Coalition of National Cancer Cooperative Groups, was again selected to manage CTSU. In this second iteration, CTSU will continue to focus on making Cooperative Group phase III treatment trials available to all Cooperative Group members and to selected sites that directly enroll via CTSU.

"Broad participation and rapid accrual have led to several important studies achieving results much faster than was possible before the advent of CTSU," said Dr. Jeff Abrams, chief of NCI's Clinical Investigations Branch in the Division of Cancer Treatment and Diagnosis (DCTD) and CTSU co-project officer.

CTSU's programs and services include regulatory support, patient registration, clinical data management, help desk support, promotion, education and training, site performance evaluation, and site financial management.

"CTSU has expanded access to NCI-funded phase III trials that previously may not have been available at a given location, thus providing patients with additional treatment options," noted Dr. Meg Mooney, head of Gastrointestinal Cancer Therapeutics for DCTD's Clinical Investigations Branch and CTSU co-project officer.

Before CTSU, investigators were limited to trials conducted by their own Cooperative Group or to specific intergroup trials. Investigators sent all regulatory materials to the Lead Cooperative Group and enrolled all patients through that Group's system. CTSU has increased physician and patient access by allowing Cooperative Group members to participate in trials coordinated by Groups to which they do not belong. CTSU has made it easy for investigators to participate in trials led by other Groups by creating a centralized location for investigators to submit regulatory documents, enroll patients, and access study documents.

Two trials that have enrolled patients more quickly than anticipated because of improved access via the CTSU are the ACOSOG Z9001 trial, a study looking at the use of imatinib (Gleevec) in gastrointestinal stromal tumors, and CALGB 90206, a study comparing the use of bevacizumab (Avastin) with interferon alfa-2B in advanced renal cell cancer - both of which have seen half or more of their enrollments enter via CTSU.

New challenges for this second edition of CTSU include creation of a centralized randomization hub for all its trials and the inclusion of trials from other NCI-sponsored trial networks, including phase II treatment studies, prevention and cancer control studies, and SPORE studies. More information about CTSU can be found at www.ctsu.org.