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

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

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

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

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