ICAS: CTOS 2005 Review of Studies U.S. NCI-funded Intergroup

ICAS: Mission and Vision NCI-funded coalition of North American cooperative oncology groups with focus in Sarcoma Research Leverage fixed infrastructures of SWOG, CALGB, ECOG, and NCI-Canada to advance publicly-funded sarcoma research

What is the Role of ICAS? Differentiation of work from other smaller groups without NCI funding and with more restricted focus of activities Where does national and international scale really need to be applied to advance research?

Strengths for Nationally Funded Sarcoma Research Effort Very large scale effectiveness studies Casting a very broad net to include the entire continent of physicians and patients Legitamacy and stability of public sector funding through NCI

Review of ICAS Studies S0033: randomized GIST testing Imatinib 400 v. 800 continuing molecular studies survival long term other sub-studies in progress

ICAS STUDIES Metastatic Disease ICAS # Sarcoma Target Agent S0330* MPNST EGF-R erlotinib S0345 DFSP PDGF-R imatinib S0346 Synovial HER2 trastuzumab S0505 All STS VEGFR+ sorafenib * First Stage accrual goal reached

ICAS STUDIES Metastatic Disease ICAS # Sarcoma Target Inhibitor S0423 Chondro MTAP pemetrexed S0502 GIST KIT/PDGFR Imatinib VEGF bevacizumab S0416 (COG) GIST (Pedi-AYA) KIT/PDGFR imatinib

The Future of ICAS Choose carefully which trials require full scope of national group mechanism Optimize efficiency for participation through inclusive investigator registration mechanism test the function and promise of the Clinical Trials Support Unit of NCI)

Patients with primary STS of the retroperitoneum or pelvis Z9031 A randomized trial of preoperative radiation plus surgery versus surgery alone for localized primary retroperitoneal STS. P.W.T. Pisters, MD Arm 1: Surgery Patients with primary STS of the retroperitoneum or pelvis R A N D O M I Z E Arm 2: XRT plus Surgery CTSU !!! A C O S O G

Complete Gross Resection Z9001 Phase III randomized double-blind study of adjuvant Imatinib versus placebo in patients following resection of primary GIST. Study Coordinator: Ronald DeMatteo, MD Primary GIST > 3 cm Successful Use of CTSU Decentralized Registrations Complete Gross Resection Tumor KIT + Randomize Placebo x 1 yr Imatinib x 1 yr

ACOSOG in Development Phase II evaluation of PET imaging as a predictor of response to neoadjuvant treatment for STS. Edward Cheng, MD (collaborative effort with ACRIN) Neoadjuvant Rx FDG-PET scan, routine staging studies (MRI and CT) Biopsy- Confirmed STS Repeat FDG-PET Wide local excision, histologic assessment of necrosis A C O S O G