EURAMOS 1

Author: Prof. Dr. med. Stefan Bielack, Julia Dobke, erstellt 2005/07/26, Last modification: 2019/09/17

Title A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy
Disease Osteosarcoma, UICC TNM II, III, IV
Type prospecitve, multicentre, randomized therapy opimizing trial
Problem / Objectives

Main objectives

  • To examine in a randomized trial, whether the addition of ifosfamide and etoposide (IE) to post-operative chemotherapy with cisplatin, doxorubicin and methotrexate improves event-free survival for patients with resectable osteosarcoma and a poor histological response to 10 weeks of pre-operative chemotherapy.
  • To examine in a randomized trial, whether the addition of pegylated interferon α-2b (ifn) as maintenance therapy after post-operative chemotherapy with cisplatin, doxorubicin and methotrexate improves event-free survival for patients with resectable osteosarcoma and a good histological response to 10 weeks of pre-operative chemotherapy.

Secondary objectives: Improvement in the following outcomes

  • Overall survival
  • Short-term toxicity
  • Long-term toxicity
  • Quality of life
Therapy / Study arms

Recruitment into the EURAMOS-1 trial ended on 30/06/2011. All newly diagnosed patients should be registered in the newly opened EURAMOS registry. The international studygroup recommends (until further notice) to treat all patients within the standard arm MAP.

The EURAMOS 1 trial is a multimodal therapy of osteosacoma with surgery and pre-and postoperative chemotherapy.
Surgery will be performed 10 weeks after pre-operative chemotherapy. Once histological response to pre-operative chemotherapy has been evaluated, patients will be randomized by contacting the relevant trials center. Randomization must be performed within 35 days from date of definitive surgery. Treatment will be allocated using permuted blocks, stratified by group, site of primary tumor and presence of metastases. A third pre-operative course of AP should not be given as this renders the patient ineligible for randomization. It is permissible to administer up to two additional MTX courses and have the patient remain eligible for randomization.

Inclusion Criteria
  • Histological evidence of high grade osteosarcoma of the extremity or axial skeleton including those arising as second malignancies
  • Resectable disease (defined as disease that is amenable or may become amenable to complete and potentially curative resection. Referral to a recognized specialist center may be appropriate)
  • Age ≤ 40 years at date of diagnostic biopsy
  • Sufficient cardiac function to receive anthracyclines: SF ≥ 28% or EF ≥ 50%
  • Registration within 30 days of diagnostic biopsy
  • Start chemotherapy within 30 days of diagnostic biopsy
  • Patient fit to undergo protocol treatment and follow-up
  • Written informed consent
Exclusion Criteria
  • Unresectable disease, primary or metastatic or both
  • Low grade osteosarcoma
  • Juxtacortical (periosteal, parosteal) osteosarcoma
  • Craniofacial osteosarcoma
  • Any previous treatment for osteosarcoma
  • Any previous chemotherapy for any disease
  • Any other medical condition precluding treatment with protocol chemotherapy (for example HIV, psychiatric disorder etc)
  • Pregnant or lactating women
Recruitment 1400 (planned after 2nd amendment)
Status 3/.06/2011: end of recruitment
EudraCT
Entry Study Register Controlled Trials: ISRCTN67613327
Principal Investigator Prof. Dr. S. Bielack
E-Mail mailto:coss@klinikum-stuttgart.de
URL http://www.coss.olgahospital-stuttgart.de
Contact

Chief investigator of the german study-group

Prof. Dr. med. Stefan Bielack
Klinikum Stuttgart - Olgahospital
Zentrum für Kinder-, Jugend- und Frauenmedizin, Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
Kriegsbergstr. 62
70174 Stuttgart
Telefon +49 (711) 278 72460
Fax +49 (711) 278 72462
s.bielack@klinikum-stuttgart.de

Coordination

Frau Dr. med. S. Hecker-Nolting
Klinikum Stuttgart - Olgahospital, Zentrum für Kinder-, Jugend- und Frauenmedizin
Pädiatrie 5 (Onkologie, Hämatologie, Immunologie), Cooperative Osteosarkom Studiengruppe (COSS)
Kriegsbergstr. 62
70174 Stuttgart
Telefon +49 (711) 278 73877
Fax +49 (711) 278 73882
COSS@klinikum-stuttgart.de

Data Manager

Matthias Kevric
Klinikum Stuttgart - Olgahospital, Zentrum für Kinder-, Jugend- und Frauenmedizin
Pädiatrie 5 (Onkologie, Hämatologie, Immunologie), Cooperative Osteosarkom Studiengruppe (COSS)
Kriegsbergstr. 62
70174 Stuttgart
Telefon +49 (711) 278 73881
Fax +49 (711) 278 72749
m.kevric@klinikum-stuttgart.de

Benjamin Sorg
Klinikum Stuttgart - Olgahospital, Zentrum für Kinder-, Jugend- und Frauenmedizin
Pädiatrie 5 (Onkologie, Hämatologie, Immunologie), Cooperative Osteosarkom Studiengruppe (COSS)
Kriegsbergstr. 62
70174 Stuttgart
Telefon +49 (711) 278 72754
Fax +49 (711) 278 73882
coss@klinikum-stuttgart.de

Participants COG, COSS, SSG, EOI
Documents
COSS-Newsletter (469KB)
Author: EURAMOS-Studie
Link(s) COSS-literature
Sponsoring Deutsche Krebshilfe; Deutsche Forschungsgemeinschaft; European Science Foundation (ESF); Medical Research Council (UK); Swedish Cancer Society and Nordic Cancer Union; Childrens Oncology Group (USA); Fonds National de Recherche Scientifique (BE); Funds for Scientific Research-Flanders (BE); Danish Medical Research Council (DK); Research Council for Health Academy of Finland (SF); Netherlands Organisation for Health Research and Development (Zon MW) (NL); The Research Council of Norway (N); Schweizerisch Pädiatrisch Onkologische Gruppe (CH); Semmelweis Foundation (CH)