chair:dr. vivien bramwell national cancer institute of canada clinical trials group sarcoma...

Chair:Chair: Dr. Vivien BramwellDr. Vivien Bramwell

NATIONAL CANCER INSTITUTE OF CANADANATIONAL CANCER INSTITUTE OF CANADACLINICAL TRIALS GROUPCLINICAL TRIALS GROUP

Sarcoma CommitteeSarcoma Committee

CANADIAN SARCOMA GROUPCANADIAN SARCOMA GROUP

Objectives - short-termObjectives - short-term

1.1. To undertake adjuvant studies to reduce recurrence and To undertake adjuvant studies to reduce recurrence and mortality due to metastases in early ASTS (Intergroup)mortality due to metastases in early ASTS (Intergroup)

• GISTGIST ACOSOG Z9001ACOSOG Z9001

-- will complete accrual in 6 - 12 monthswill complete accrual in 6 - 12 months

-- Canadian accrual approx. 10%Canadian accrual approx. 10%

• STSSTS INTERGROUPINTERGROUP

-- Canadian participation in EORTC 62931 (closedCanadian participation in EORTC 62931 (closed

December 2003)December 2003)

-- several Intergroup proposals for RCT have failed, several Intergroup proposals for RCT have failed, no agreement on appropriate control arm,no agreement on appropriate control arm,

limited efficacy current regimens in limited efficacy current regimens in advanced STSadvanced STS

SARCOMA COMMITTEE/CANADIAN SARCOMA GROUPSARCOMA COMMITTEE/CANADIAN SARCOMA GROUP


2.2. To perform empirical screening and/or rationally targeted To perform empirical screening and/or rationally targeted studies of IND in chemotherapy-naïve patients across studies of IND in chemotherapy-naïve patients across spectrum ASTSspectrum ASTS

• four phase II studies completed, published in last 10 yrsfour phase II studies completed, published in last 10 yrs

• chemo-naïve patients, Intergroup collaboration in EORTC 62012 chemo-naïve patients, Intergroup collaboration in EORTC 62012

– – phase III trial of single agent DOX vs dose intense phase III trial of single agent DOX vs dose intense DOX/IFOSDOX/IFOS

–– start Fall 2006start Fall 2006



3.3. To assess molecularly targeted therapies in histology-To assess molecularly targeted therapies in histology-specific trials in patients who have failed conventional specific trials in patients who have failed conventional chemotherapy (Intergroup)chemotherapy (Intergroup)

ICASICAS Intergroup Coalition Against SarcomasIntergroup Coalition Against Sarcomas• funded through SWOG operating grantfunded through SWOG operating grant• involves NCIC-CTG, ECOG, CALGBinvolves NCIC-CTG, ECOG, CALGB

shared studies with RTOG, ACOSOG, COGshared studies with RTOG, ACOSOG, COG• S0033 imatinib in GIST (closed September 2001)S0033 imatinib in GIST (closed September 2001)

–– accrued 746 pts in 9 mos (Canadian 7%)accrued 746 pts in 9 mos (Canadian 7%)• 4 IND studies open – accruing through SWOG4 IND studies open – accruing through SWOG• 3 on CTSU (1 awaiting Canadian activation, 2 declined)3 on CTSU (1 awaiting Canadian activation, 2 declined)• 3 future ICAS CTSU studies – Canadian interest3 future ICAS CTSU studies – Canadian interest• 1 protocol, Canadian PI (Q. Chu) in development1 protocol, Canadian PI (Q. Chu) in development


Objectives - medium-termObjectives - medium-term

4.4. To use research findings generated through the CSG To use research findings generated through the CSG TB/DB and/or IHRT program to plan future correlative TB/DB and/or IHRT program to plan future correlative science projects/clinical trialsscience projects/clinical trials

• CSG TB/DB (approximately 900 frozen/fixed tumors andCSG TB/DB (approximately 900 frozen/fixed tumors and data) data) currently funded and maintained as part of larger TB/DB currently funded and maintained as part of larger TB/DB through IHRT program Mt. Sinai, Torontothrough IHRT program Mt. Sinai, Toronto

• IHRT program may morph into CanSarc (pending funding CIHR)IHRT program may morph into CanSarc (pending funding CIHR)

• IHRT/CanSarc projects, in future, may need national clinical IHRT/CanSarc projects, in future, may need national clinical trials involvementtrials involvement


5.5. To build on local control, survival and functional To build on local control, survival and functional outcome data from SR2 study, to plan future studies outcome data from SR2 study, to plan future studies that will optimize local control and reduce morbidity in that will optimize local control and reduce morbidity in locoregional ASTSlocoregional ASTS

• translational, pilot studies ongoing through IHRT/CanSarctranslational, pilot studies ongoing through IHRT/CanSarc

• also may lead to future proposals for multicentre trialsalso may lead to future proposals for multicentre trials


Objectives - medium-termObjectives - medium-term

chair:dr. vivien bramwell national cancer institute of canada clinical trials group sarcoma...

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