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ACOSOG Clinical Trials

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%

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ACOSOG Clinical Trials

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  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. 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

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