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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002539
Other study ID # EORTC-80931
Secondary ID EOI-80931EORTC-8
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated September 20, 2012
Start date August 1993

Study information

Verified date September 2012
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date
Est. primary completion date October 2002
Accepts healthy volunteers No
Gender Both
Age group N/A to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
filgrastim

Drug:
cisplatin

doxorubicin hydrochloride

Procedure:
conventional surgery


Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels (Bruxelles)
Belgium Institut Jules Bordet Brussels (Bruxelles)
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium U.Z. Gasthuisberg Leuven
Denmark Aarhus Kommunehospital Aarhus
Denmark Rigshospitalet Copenhagen
France Centre Eugene Marquis Rennes
Netherlands Emma Kinderziekenhuis Amsterdam
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Leiden University Medical Center Leiden
Netherlands University Medical Center Nijmegen Nijmegen
Netherlands Academisch Ziekenhuis Utrecht Utrecht
Portugal Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa Lisbon
Saudi Arabia King Faisal Specialist Hospital and Research Centre Riyadh
Slovenia Institute of Oncology, Ljubljana Ljubljana
United Kingdom St. James's Hospital Leeds England

Sponsors (2)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC Medical Research Council

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Netherlands,  Portugal,  Saudi Arabia,  Slovenia,  United Kingdom, 

References & Publications (2)

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

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 his — View Citation

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