ACOSOG Clinical Trials

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 gt 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