ICAS CTOS 2005 Review of Studies U S

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

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 ICAS Intergroup Coalition Against Sarcomas

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? ICAS Intergroup Coalition Against Sarcomas

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 ICAS Intergroup Coalition Against Sarcomas

Review of ICAS Studies • S 0033: randomized GIST testing Imatinib 400 v. 800 – – – continuing molecular studies survival long term other sub-studies in progress ICAS Intergroup Coalition Against Sarcomas

ICAS STUDIES Metastatic Disease ICAS # Sarcoma Target Agent S 0330* MPNST EGF-R erlotinib S 0345 DFSP PDGF-R imatinib S 0346 Synovial HER 2 S 0505 All STS VEGFR+ sorafenib * First Stage accrual goal reached trastuzumab

ICAS STUDIES Metastatic Disease ICAS # Sarcoma Target S 0423 Chondro MTAP S 0502 GIST Inhibitor pemetrexed KIT/PDGFR Imatinib VEGF bevacizumab S 0416 (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) ICAS Intergroup Coalition Against Sarcomas

Z 9031 radiation plus A randomized trial of preoperative surgery versus surgery alone for localized primary retroperitoneal STS. P. W. T. Pisters, MD Patients with primary STS of the retroperitoneum or pelvis CTSU !!! Arm 1: Surgery R A N D O M I Z ACOSOG E Arm 2: XRT plus Surgery ICAS Intergroup Coalition Against Sarcomas

Z 9001 Phase III randomized double-blind study of adjuvant Imatinib versus placebo in patients following resection of primary GIST. Study Coordinator: Ronald De. Matteo, MD Primary GIST > 3 cm Complete Gross Resection Tumor KIT + Randomize Placebo x 1 yr Successful Use of CTSU Decentralized Registrations Imatinib x 1 yr ICAS Intergroup Coalition Against Sarcomas

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 Biopsy. Confirmed STS FDG-PET scan, routine staging studies (MRI and CT) Repeat FDG-PET Wide local excision, histologic assessment of necrosis ACOSOG ICAS Intergroup Coalition Against Sarcomas