The Cancer Trials Support Unit (CTSU)

Steve Riordan, Project DirectorJenny Hopkins, Task ManagerCTSU/Westat, Rockville, MD

June 26, 2007Clinical 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 TrialsCancer Site / Type Active Closed Active and Closed In Development

Breast 19 13 32 7

Genitourinary 11 13 24 3

Gastrointestinal 8 8 16 2

Leukemia 5 2 7 4

Gynecologic 4 2 6 0

Lung 3 10 13 4

Lymphoma 3 0 3 0

Head and Neck 2 3 5 1

Myeloma 1 2 3 2

Melanoma 1 0 1 0

Non-specific correlative 1 0 1 0

Metastatic Cancer 1 1 2 1

Sarcoma 1 1 2 0

Carcinoid 0 0 0 1

CNS Primary 0 0 0 2

GI Stromal Tumor 0 2 2 1

Total 60 57 117 28

CTSU Study Activity:As of May 31, 2007 – Top 14 Trials in Accrual (* = Metastatic Trial)

Trial # Title SiteNCIC-MA.27 Exemestane vs Anastrozole BreastCALGB-40101 CA (4 vs 6 cycles) vs Paclitaxel (4 vs 6 cycles) BreastNSABP-B-39 Whole Breast Irradiation vs Partial Breast Irradiation BreastNSABP-B-38 TAC vs DD AC-P vs DD AC-PG BreastN0147 mFOLFOX6 vs mFOLFOX6 + Cetuximab ColonPACCT1 TailoRx (Onco-Type DX) BreastNSABP-B-35 Anastrozole vs Tamoxifen in DCIS BreastS0221 Contin. AC+G vs Q 2 wk AC->P (Q 2 vs Q 12 wks) BreastIBCSG-25-02 Role of Exemestane Plus GnRH Analogue BreastIBCSG-24-02 Role of Ovarian Function Suppression & Exemestane BreastNSABP-C-08 mFOLFOX6 vs mFOLFOX6 + Bevacizumab ColonC80405 Chemo/BV vs Chemo/C225 vs Chemo/BV/C225 * CRCNSABP-B-30 ACT vs AC vs ACT BreastACOSOG-Z9001 Imatinib vs Placebo GIST

CTSU Cumulative AccrualCTSU Accrual Summary

May 31, 2007

502444

551505 484 491 476

439 420

531468

548

17,256 17,69918,250 18,754 19,236 19,727 20,203 20,642 21,062 21,591 22,059

22,607

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1,400

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For More Information…

• CTSU Web Site– Public: http://www.ctsu.org– Member: https://members.ctsu.org (requires

username and password)

• CTSU Help Desk– 1-888-823-5923– CTSUContact@westat.com