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EURAMOS 1
A randomised trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on
histological response to pre-operative chemotherapy
Jeremy Whelan for the EURAMOS 1 Trial Management Group, 4th November 2006
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EURAMOS
• EURAMOS is the European and American Osteosarcoma Study Group. The study was founded in 2001. Children’s Oncology Group Cooperative Osteosarcoma Study Group European Osteosarcoma Intergroup Scandinavian Sarcoma Group
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EURAMOS
• Established Oct 2001• Aim
to improve survival from OS
• Objectives to carry out large international randomised trials to facilitate biological research to seek new therapeutic approaches to develop common understanding and
methodologies for staging, pathology etc.
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EURAMOS 1
• Co-sponsored MRC in Europe COG for North America
• Co-ordinating Data Centre MRC Clinical Trials Unit
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Trial Design
E U R A M O S 1
M A P M A P ifn
R A N D O M IS E
G ood
M A P M A P IE
R A N D O M IS E
P o or
H is to log ica l a sse ssm e nto f resp on se
S u rg e ry
In d uc tio n T h era pyM A P
R E G IS T E R
B io psy-p ro ve n d iag n o sis o fre sec ta b le os te osa rco m a
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Trial Design
• Key registration criteria High grade OS of extremity or axial skeleton Resectable disease Fit for treatment
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Trial Design
• Key randomisation criteria Adequate pre-operative chemotherapy Macroscopically complete resection of primary tumour Complete removal of all metastases or complete removal
planned and feasible Histological response assessment
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Trial Design
• Primary Objectives Addition of IE to post-op MAP chemotherapy
improves EFS for poor responders Addition of ifn to post-op MAP chemotherapy
improves EFS for good responders
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Trial Design
• Secondary Objectives Additional treatment improves OS, short and
long term toxicity and quality of life Additional treatment improves EFS in localised
disease Investigate biological and clinical correlated to
histological response and outcome International cooperation in trials Examine outcome of the entire cohort of patients
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Trial Design- additional studies
• Quality of Life• Biology Studies
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EURAMOS participants
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Progress: open and recruiting
Registered Randomised
USA 111 40
Germany 87 42
UK 42 17
Netherlands 14 5
Norway 11 4
Canada 10 2
Belgium 9 5
Switzerland 8 5
Sweden 5 3
Demark 2 0
Hungary 1 0
Australia 2 0
Total 302 123
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Progress: almost ready
• Austria• Finland
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Progress: requests to join
• Czech Republic• Ireland• Poland• Israel
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Accrual
0
200
400
600
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Cu
mu
lativ
e r
eg
istr
atio
ns
Jan
-05
Jul-
05
Jan
-06
Jul-
06
Jan
-07
Jul-
07
Jan
-08
Jul-
08
Jan
-09
Jul-
09
Date of registration
Observed Expected
Cumulative registrations overall
302 Registered
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Accrual
• 302 Registered
0
10
20
30
40
Num
ber
of p
atie
nts
2005
09
2005
10
2005
11
2005
12
2006
01
2006
02
2006
03
2006
04
2006
05
2006
06
2006
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2006
08
2006
09
Monthly registrations by Group
COG COSS EOI SSG
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Accrual
0
5
10
15
20
Num
ber
of p
atie
nts
2005
09
2005
10
2005
11
2005
12
2006
01
2006
02
2006
03
2006
04
2006
05
2006
06
2006
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2006
08
2006
09
Monthly randomisations by Group
COG COSS EOI SSG
123 Randomised
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EURAMOS 1
• Chief Investigators Mark Bernstein (TMG Chair) Neyssa Marina (COG) Stephan Bielack (COSS) Jeremy Whelan (EOI) Sigbjorn Smeland (SSG)
• Website www.euramos.org