|
|
|
|
|
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 |
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 |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: filgrastim Procedure: conventional surgery |
Phase III |
MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Filgrastim Cisplatin Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor |
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 |
Study Start Date: | August 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | up to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
European Organization for Research and Treatment of Cancer |
Medical Research Council |
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 |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002539 |
Health Authority: | United States: Federal Government |
|
|
|
|
|