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

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

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.

EURAMOS 1

• Co-sponsored MRC in Europe COG for North America

• Co-ordinating Data Centre MRC Clinical Trials Unit

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

Trial Design

• Key registration criteria High grade OS of extremity or axial skeleton Resectable disease Fit for treatment

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

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

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

Trial Design- additional studies

• Quality of Life• Biology Studies

EURAMOS participants

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

Progress: almost ready

• Austria• Finland

Progress: requests to join

• Czech Republic• Ireland• Poland• Israel

Accrual

0

200

400

600

800

1000

1200

1400

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

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

07

2006

08

2006

09

Monthly registrations by Group

COG COSS EOI SSG

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

07

2006

08

2006

09

Monthly randomisations by Group

COG COSS EOI SSG

123 Randomised

EURAMOS 1

• Chief Investigators Mark Bernstein (TMG Chair) Neyssa Marina (COG) Stephan Bielack (COSS) Jeremy Whelan (EOI) Sigbjorn Smeland (SSG)

• Website www.euramos.org