Trial Information

A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA

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 continuously on day 1. Treatment continues every 3 weeks for 2
courses. At week 6, patients undergo amputation or local resection based on pretherapy
imaging and response to chemotherapy. Beginning 2 weeks after surgery, patients receive
4 additional courses of conventional chemotherapy.

- Arm II: Patients receive intensive DOX and CDDP as above on day 1 plus filgrastim
(G-CSF) subcutaneously on days 4-13. Treatment continues every 2 weeks for 3 courses.
At week 6, patients undergo definitive surgery as in arm I. Beginning 2 weeks after
surgery, patients receive 3 additional courses of intensive DOX and CDDP with G-CSF.

Patients who experience disease progression during preoperative chemotherapy undergo surgery
earlier than scheduled and complete all scheduled chemotherapy (6 courses) after surgery, at
the discretion of the surgeon and oncologist. Within 4 weeks after limb-sparing procedure,
patients with inadequate margins undergo amputation, followed 2 weeks later by chemotherapy.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for
1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.