1 / 5

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%

gwendolyn-fuller
Download Presentation

ACOSOG Clinical Trials

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related