1. ACOSOG Clinical Trials
Robert Maki, MD, PhD
for
Peter Pisters, MD
Sarcoma Committee Chair

2. Closed study Z9000: High risk GIST phase II adjuvant study
Ron DeMatteo, MD, P.I.
GIST ≥ 10 cm, ruptured, peritoneal bleeding, or satellite nodules
Recurrence risk > 80%
Rx imatinib 400 mg daily x 1 year
n = 106
Closed 29 Aug 2003
1st interim analysis early in 2006

3. Z9001: GIST adjuvant study Ron DeMatteo, MD, P.I. Resected GIST ≥ 3 cm
Imatinib 400 mg daily vs. placebo x 1 year
Primary endpoint: relapse-free survival
Activated 1 June 2002
Expanded enrollment from 489 to goal of 732 patients
Lower risk patients are being enrolled than typically seen for this disease, indicating significant number of patients may be receiving imatinib in an off-study setting
Enrollment to date: 450+
Accrual rate: 20 per month
Expected completion time for accrual: Early 2007

4. Z9031: Phase III neoadjuvant radiation vs
Z9031: Phase III neoadjuvant radiation vs. nil for retroperitoneal sarcomas
Peter Pisters, MD, P.I.
Radiation dose: 45 – 50.4 Gy pre-op
Endpoint: progression free survival
Activated 23 Aug 2004
Accrual goal: 370 patients
Low accrual: ~20 to date
Difficulty in having patients receive radiation far from home
Typical practice in U.S. specialty centers much more commonly involves recurrent patients rather than those with new diagnoses
Options: expand accruing sites (would need international effort), close / change study to include recurrent patients

5. Z9041 / S0344: Intralesional resection of low-grade intracompartmental chondrosarcoma
SWOG study in which ACOSOG is participating
Should yield outcome data for conservative management of these low grade lesions
Lor Randall, MD, P.I.
Phase II study, 60 patient accrual goal
Activated 1 Dec 2004 (SWOG), 6 April 2005 (ACOSOG)
Enrollment ~5 at present, 2 pending