A randomized trial of the European and American Osteosarcoma Study Group to optimaze treatment strategies for respectable osteosarcoma based on histological response to pre-operative chemotherapy

• Conditions: Patients with diagnosis resectable osteosarcoma.

• Registration Number: EUCTR2004-000242-20-CZ
• Lead Sponsor: MRC Clinical Trials Unit, Cancer Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-12
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histological evidence of high grade osteosarcoma of the extremity or axial skeleton incl. those arising as second malignancies
Resectable disease
Age < 18 years at date of diagnostic biopsy
Registration within 30 days of diagnostic biopsy
Start chemotherapy within 30 days of diagnostic biopsy
Neutrophils > 1,5 x 10E9/L, platelet count > 100 x 10E9/L
GF > 70 ml/min/1.73 m2
Serum bilirubin < 1.5 x ULN
Sufficient cardiac function: SF > 28% or EF > 50%
Karnofsky score > 60 (age > 16 years), Lansky > 60 (age < 16 years)
Patients fit to undergo protocol treatment and follow-up
Written informed concent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unresectable disease, primary or metastatic or both
Low grade osteosarcoma
Juxtacortical osteosarcoma
Craniofacial osteosarcoma
Any previous treatment for osteosarcoma
Any previous chemotherapy for any disease
Any other medical condition precluding treatment with protocol chemotherapy (e.g. HIV, psychiatric disorder etc.)
Pregnant or lactating women
Exclusion of patients with PegIntron contraindications – see SPC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified