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 - a phase III intergroup study

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1. ClinicalTrials.gov url

   http://clinicaltrials.gov/ct2/show/NCT00134030?term=COG+AOST0331&rank=1

2. Intervention

   Ifosfamide

3. Intervention

   Etoposide

4. Intervention

   PEG-interferon alfa-2b

5. Intervention

   Cisplatin

6. Intervention

   Methotrexate

7. Intervention

   Doxorubicin hydrochloride

8. Additional Topic(s)

   MAP therapy

9. Resource Description

   The standard anti-cancer drugs used to treat patients with osteosarcoma are doxorubicin, cisplatin, and methotrexate (together called MAP therapy). In previous research studies using MAP, it was found that if the tumor cells are almost all destroyed (about 90% or more, called a good response) by MAP, there is a good chance that the tumor can be cured by continuing to use these standard drugs. If the tumor cells are not as easily killed by MAP (less than 90% of the cells killed, called a poor response), the chance of cure is not as good, meaning the tumor is more likely to return later. For children and adolescents who do not have a good tumor response to MAP, this study aims to find out if adding two other common anti-cancer drugs (ifosfamide and etoposide) will help cure more patients. For children and adolescents who have a good tumor response to MAP therapy, study doctors would like to know if adding a “biologic” drug, interferon, after MAP, will help make sure the tumor cells do not return later. The aims of this study are: To see if the addition of ifosfamide and etoposide to MAP chemotherapy will help cure patients who have a poor tumor response to MAP alone. To see if the addition of interferon after MAP chemotherapy can help improve cure rates in children and adolescents who have a good tumor response to standard chemotherapy.

10. Additional Name

    Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

11. Topic

    osteosarcoma

12. Study Population

    Males and females between ages 5 and 40 with high grade osteosarcoma, including second malignancies, which meet other tumor-related and laboratory test requirements

13. Funded by

    Children's Oncology Group

14. Phase

    Phase 3 clinical trial

15. Performed by

    Clinical Protocol & Data Management Shared Resource