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

NCT00002539 | Completed Phase 3

• 4 other identifiers: EORTC-80931EOI-80931MRC-BO06EU-93024
• Study Type: interventional
• Target: 214
• Locations: 8 countries
• Sites: 16

Brief Summary

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.

Conditions

Sarcoma

Keywords

localized osteosarcoma

Interventions

filgrastim BIOLOGICAL

cisplatin DRUG

doxorubicin hydrochloride DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Medical Research Council: collaborator

Study Sites (16)

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels (Bruxelles), 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus Kommunehospital

Aarhus, DK-8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Emma Kinderziekenhuis

Amsterdam, NL-1100 DE, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa

Lisbon, 1099-023 Codex, Portugal

Location

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 17227995 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Filgrastim; Cisplatin; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides

Study Officials

• Marianne A. Nooij, MD

  Leiden University Medical Center

  STUDY CHAIR

• Ian J. Lewis, MD

  Leeds Cancer Centre at St. James's University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 10, 2003
• Study Start: August 1, 1993
• Primary Completion: October 1, 2002
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

SL (1); BE (4); PT (1); NL (5); DK (2); GB (1); FR (1); SA (1)