Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA|
|Study Start Date:||August 1993|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002539
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Cliniques Universitaires Saint-Luc|
|Brussels (Bruxelles), Belgium, 1200|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Aarhus, Denmark, DK-8000|
|Copenhagen, Denmark, 2100|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Amsterdam, Netherlands, NL-1100 DE|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa|
|Lisbon, Portugal, 1099-023 Codex|
|King Faisal Specialist Hospital and Research Centre|
|Riyadh, Saudi Arabia, 11211|
|Institute of Oncology, Ljubljana|
|Ljubljana, Slovenia, Sl-1000|
|St. James's Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Study Chair:||Marianne A. Nooij, MD||Leiden University Medical Center|
|Study Chair:||Ian J. Lewis, MD||Leeds Cancer Centre at St. James's University Hospital|