Clinical Trials in Osteosarcoma
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
Collaboration of the North American Children's Oncology Group (COG), the German-Austrian-Swiss Cooperative Osteosarcoma Study Group (COSS), the EuropeanOsteosarcoma Intergroup (EOI) and the Scandinavian Sarcoma Group (SSG).
Official Title: Phase III Randomized Study of Neoadjuvant Induction Therapy Comprising Doxorubicin, Cisplatin, and High-Dose Methotrexate (MAP) Followed by Surgery and Adjuvant Maintenance Therapy Comprising MAP Alone Versus MAP and PEG-Interferon Alfa-2b OR MAP Combined With Ifosfamide and Etoposide in Patients With Resectable High-Grade Osteosarcoma.
Primary Objectives:
- Compare whether adjuvant maintenance therapy comprising doxorubicin, cisplatin, and high-dose methotrexate (MAP) alone vs MAP combined with ifosfamide and etoposide improves event-free survival of patients with resectable high-grade osteosarcoma who achieve a poor histological response (HR) to neoadjuvant induction therapy comprising MAP.
- Compare whether adjuvant maintenance therapy comprising MAP alone vs MAP and PEG-interferon alfa-2b improves event-free survival of patients with resectable high-grade osteosarcoma who achieve a good HR to neoadjuvant induction therapy comprising MAP.
Eligibility (main criteria)
Ages: 5 Years - 40 Years
Disease Characteristics:
- Histologically confirmed high-grade osteosarcoma, including second malignancies
- Localized or metastatic disease
- Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
- Suitable for neoadjuvant chemotherapy
Location and Contact Information
United States
Children's Oncology Group
Check Cure search for Treatment Center
Canada, Quebec
Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada; Recruiting
Mark L. Bernstein, MD, FRCPC 514-345-4969
Germany
Olgahospital, Stuttgart, D-70176, Germany; Recruiting
Stefan Bielack, MD: 49-711-99-24-61;
E-mail
Norway
Norwegian Radium Hospital, Oslo, N-0310, Norway; Recruiting
Sigbjorn Smeland: 47-2293-4800
United Kingdom, England
University College Hospital, London, England, WC1E 6AU, United Kingdom; Recruiting
Jeremy Whelan, MD: 44-020-7380-9346;
E-mail
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