Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Apr 9, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the overall and disease-free survival of patients with newly diagnosed osteosarcoma of the extremity treated with conventional vs intensive cisplatin and doxorubicin with or without filgrastim (G-CSF) before and after definitive surgery.
* Compare the toxicity of these regimens in these patients.
* Compare the response in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive conventional doxorubicin (DOX) IV over 4 hours on days 1-3 and cisplatin (CDDP) IV...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically proven resectable osteosarcoma of the long bone of an extremity
• • No parosteal (juxtacortical), periosteal, Pagetoid, or post-irradiation sarcoma
• • No distant metastases
• PATIENT CHARACTERISTICS:
• Age:
• • 40 and under
• Performance status:
• • Not specified
• Life expectancy:
• • Not specified
• Hematopoietic:
• • Neutrophil count at least 1,500/mm\^3 OR
• • WBC at least 3,500/mm\^3
• • Platelet count at least 100,000/mm\^3
• Hepatic:
• • Bilirubin no greater than 1.2 mg/dL
• Renal:
• • Glomerular filtration rate at least 60 mL/min
• Cardiovascular:
• • No history of cardiac dysfunction
• Other:
• • No other prior or concurrent malignancy except basal cell skin cancer OR
• • Carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Not specified
• Chemotherapy:
• • No other concurrent chemotherapy
• Endocrine therapy:
• • Not specified
• Radiotherapy:
• • See Disease Characteristics
• Surgery:
• • See Disease Characteristics
• Other:
• • No prior therapy

Trial Officials