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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
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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 ofSWOG, CALGB, ECOG, and NCI-Canadato 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 ofpublic 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 STUDIESMetastatic Disease ICAS #SarcomaTargetAgent 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 STUDIESMetastatic Disease ICAS #SarcomaTargetInhibitor 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 theClinical Trials Support Unit of NCI)
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
Z9001 Phase III randomized double-blind study ofadjuvant Imatinib versus placebo in patientsfollowing 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