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

Sponsors and Collaborators:	European Organization for Research and Treatment of Cancer Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002539

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Myocet Filgrastim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 1993

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002539

Locations

Belgium
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), Belgium, 1200
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Denmark
Aarhus Kommunehospital
Aarhus, Denmark, DK-8000
Rigshospitalet
Copenhagen, Denmark, 2100
France
Centre Eugene Marquis
Rennes, France, 35064
Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Emma Kinderziekenhuis
Amsterdam, Netherlands, NL-1100 DE
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Portugal
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, Portugal, 1099-023 Codex
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 11211
Slovenia
Institute of Oncology, Ljubljana
Ljubljana, Slovenia, Sl-1000
United Kingdom, England
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Medical Research Council

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	CDR0000078531, EOI-80931, EORTC-80931, MRC-BO06, EU-93024
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002539 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized osteosarcoma

Study placed in the following topic categories:

Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Cisplatin

Sarcoma
Osteogenic Sarcoma
Osteosarcoma
Doxorubicin

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Antineoplastic Agents
Therapeutic Uses

Sarcoma
Osteosarcoma
Neoplasms, Connective Tissue
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin

ClinicalTrials.gov processed this record on July 02, 2009