The Cancer Trials Support Unit (CTSU) Steve Riordan, Project Director Jenny Hopkins, Task Manager CTSU/Westat, Rockville, MD June 26, 2007 Clinical Trials.

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Presentation transcript:

The Cancer Trials Support Unit (CTSU) Steve Riordan, Project Director Jenny Hopkins, Task Manager CTSU/Westat, Rockville, MD June 26, 2007 Clinical Trials Break Out Session

Goals of the CTSU Increase and simplify access to clinical trials Offer a wide choice of clinical trials and speed enrollment to multi-site clinical trials Consolidate/off-load duplicative administrative and regulatory activities across the adult Cooperative Groups Provide necessary support services for accrual and centralization of services

Scope of the CTSU United States and Canada –International Sites of US Groups Phase 3 adult cancer treatment trials –Breast, GI, GU, GYN, Head & Neck, Leukemia, Lung, Lymphoma, Sarcoma, others Selected Phase 2 adult cancer treatment trials Over 65 active trials for adults with cancer Over 22,000 enrollments since 1999

Scope of CTSU - Activities Patient Registrations Accrual Reimbursement Protocol Coordination Clinical Data Operations Regulatory Support Services Financial Management Information Technology Development Site Auditing Site Quality Assurance CTSU Help Desk CTSU Web Site Promotion, Education and Training CTSU Independent Clinical Research Sites (CICRS) Program

CTSU Menu of Trials Cancer Site / TypeActiveClosedActive and ClosedIn Development Breast Genitourinary Gastrointestinal88162 Leukemia5274 Gynecologic4260 Lung Lymphoma3030 Head and Neck2351 Myeloma1232 Melanoma1010 Non-specific correlative1010 Metastatic Cancer1121 Sarcoma1120 Carcinoid0001 CNS Primary0002 GI Stromal Tumor0221 Total

CTSU Study Activity: As of May 31, 2007 – Top 14 Trials in Accrual (* = Metastatic Trial) Trial #TitleSite NCIC-MA.27 Exemestane vs Anastrozole Breast CALGB CA (4 vs 6 cycles) vs Paclitaxel (4 vs 6 cycles) Breast NSABP-B-39 Whole Breast Irradiation vs Partial Breast Irradiation Breast NSABP-B-38 TAC vs DD AC-P vs DD AC-PG Breast N0147 mFOLFOX6 vs mFOLFOX6 + Cetuximab Colon PACCT1 TailoRx (Onco-Type DX) Breast NSABP-B-35 Anastrozole vs Tamoxifen in DCIS Breast S0221 Contin. AC+G vs Q 2 wk AC->P (Q 2 vs Q 12 wks) Breast IBCSG Role of Exemestane Plus GnRH Analogue Breast IBCSG Role of Ovarian Function Suppression & Exemestane Breast NSABP-C-08 mFOLFOX6 vs mFOLFOX6 + Bevacizumab Colon C80405 Chemo/BV vs Chemo/C225 vs Chemo/BV/C225 *CRC NSABP-B-30 AC  T vs AC vs ACT Breast ACOSOG-Z9001 Imatinib vs Placebo GIST

CTSU Cumulative Accrual

For More Information… CTSU Web Site –Public: –Member: (requires username and password) CTSU Help Desk –