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 Breast

CALGB-40101 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-25-02 Role of Exemestane Plus GnRH Analogue Breast

IBCSG-24-02 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 ACT vs AC vs ACT Breast

ACOSOG-Z9001 Imatinib vs Placebo GIST

CTSU Cumulative AccrualCTSU Accrual Summary

May 31, 2007

502

444

551505 484 491 476

439 420

531

468

548

17,256 17,69918,250

18,75419,236

19,72720,203 20,642 21,062

21,59122,059

22,607

200

400

600

800

1,000

1,200

1,400

2006-06

2006-07

2006-08

2006-09

2006-10

2006-11

2006-12

2007-01

2007-02

2007-03

2007-04

2007-05

Mo

nth

ly A

ccru

al

0

4,000

8,000

12,000

16,000

20,000

24,000

Cu

mu

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ccru

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Monthly Cumulative

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