Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
NCT ID: NCT00002539
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
1993-08-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
cisplatin
doxorubicin hydrochloride
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Marianne A. Nooij, MD
Role: STUDY_CHAIR
Leiden University Medical Center
Ian J. Lewis, MD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Institut Jules Bordet
Brussels (Bruxelles), , Belgium
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Aarhus Kommunehospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Centre Eugene Marquis
Rennes, , France
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Emma Kinderziekenhuis
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, , Portugal
King Faisal Specialist Hospital and Research Centre
Riyadh, , Saudi Arabia
Institute of Oncology, Ljubljana
Ljubljana, , Slovenia
St. James's Hospital
Leeds, England, United Kingdom
Countries
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References
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Lewis IJ, Nooij MA, Whelan J, Sydes MR, Grimer R, Hogendoorn PC, Memon MA, Weeden S, Uscinska BM, van Glabbeke M, Kirkpatrick A, Hauben EI, Craft AW, Taminiau AH; MRC BO06 and EORTC 80931 collaborators; European Osteosarcoma Intergroup. Improvement in histologic response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst. 2007 Jan 17;99(2):112-28. doi: 10.1093/jnci/djk015.
Lewis IJ, Nooij M: Chemotherapy at standard or increased dose intensity in patients with operable osteosarcoma of the extremity: a randomised controlled trial conducted by the European Osteo Sarcoma Intergroup (ISRCTN 86294690). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3281, 816, 2003.
Other Identifiers
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EOI-80931
Identifier Type: -
Identifier Source: secondary_id
EORTC-80931
Identifier Type: -
Identifier Source: secondary_id
MRC-BO06
Identifier Type: -
Identifier Source: secondary_id
EU-93024
Identifier Type: -
Identifier Source: secondary_id
EORTC-80931
Identifier Type: -
Identifier Source: org_study_id