Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma
NCT ID: NCT00470223
Last Updated: 2025-06-08
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
318 participants
INTERVENTIONAL
2007-03-31
2026-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.
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Detailed Description
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Primary
* Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Compare the percentage of patients with a good histologic response.
* Compare the long and short term toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 18 years vs 18-25 years vs \> 25 years), risk group (nonmetastatic or resectable vs metastatic or unresectable), and treatment center. Patients receive either methotrexate-based chemotherapy or doxorubicin hydrochloride-based chemotherapy according to age.
* Methotrexate-based chemotherapy (patients ≤ 25 years of age): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive methotrexate IV in weeks 1-3, 7, 8, 12, and 13 and etoposide IV and ifosfamide IV in weeks 4 and 9.
* Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I. Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.
All patients undergo surgery in week 14. After surgery, patients are assigned to 1 of 2 groups for further treatment, based on histological response.
* Good responders (\< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive methotrexate IV in weeks 1-3, 7-9, 13-15, and 19-21 and etoposide IV in weeks 4 and 10. Patients also receive ifosfamide IV in weeks 4, 10, and 16.
* Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I. Patients also receive zoledronic acid IV in weeks 3, 7, 11, 15, 19, and 23.
* Bad responders (\> 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive methotrexate IV in weeks 1, 5, 9, 13, and 17 and doxorubicin hydrochloride IV and cisplatin IV in weeks 2, 6, 10, 14, and 18.
* Arm II: Patients receive methotrexate, doxorubicin hydrochloride, and cisplatin as in arm I. Patients also receive zoledronic acid IV as in arm II (good responders).
* Doxorubicin hydrochloride-based chemotherapy (patients ≥ 18 years of age): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive doxorubicin hydrochloride IV and ifosfamide hydrochloride IV in weeks 1, 4, 7, 10, and 13 and cisplatin IV in weeks 1, 7, and 13.
* Arm II: Patients receive doxorubicin hydrochloride, ifosfamide, and cisplatin as in arm I. Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.
All patients undergo surgery in week 16. After surgery, patients are assigned to 1 of 2 groups for further treatment, based on histological response.
* Good responders (\< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive doxorubicin hydrochloride IV in weeks 1 and 7 and ifosfamide IV in weeks 1, 4, 7, and 10.
* Arm II: Patients receive doxorubicin hydrochloride and ifosfamide as in arm I. Patients also receive zoledronic acid IV in weeks 1, 5, 9, 13, 17, and 21.
* Bad responders (\> 10% viable cells):
* Arm I: Patients receive etoposide IV and ifosfamide IV in weeks 1, 4, 7, 10, and 13.
* Arm II: Patients receive etoposide and ifosfamide as in arm I. Patients also receive zoledronic acid as in arm II (good responders).
PROJECTED ACCRUAL: A total of 440 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy + zoledronic acid
cisplatin
doxorubicin hydrochloride
etoposide
ifosfamide
methotrexate
zoledronic acid
conventional surgery
chemotherapy
cisplatin
doxorubicin hydrochloride
etoposide
ifosfamide
methotrexate
conventional surgery
Interventions
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cisplatin
doxorubicin hydrochloride
etoposide
ifosfamide
methotrexate
zoledronic acid
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Bilirubin ≤ 2 times upper limit of normal
* No medical condition that would preclude study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Shortening fraction ≥ 28%
* LVEF ≥ 50%
* Glomerular filtration rate ≥ 70mL/min
* No recent dental problem, including infection, traumatization, or surgery
Exclusion Criteria
* Small cell osteosarcoma
* Maxillary osteosarcoma
* Primary resected osteosarcoma
* Osteosarcoma with multiple metastases for which complete removal is not feasible even after shrinkage with chemotherapy
* Extra-osseous osteosarcoma
* Any prior osteonecrosis of the maxilla
* No prior chemotherapy or radiotherapy
5 Years
50 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Chugai Pharmaceutical
INDUSTRY
National Cancer Institute, France
OTHER_GOV
SFCE
UNKNOWN
Ligue contre le cancer, France
OTHER
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Laurence Brugieres, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Centre Paul Papin
Angers, , France
Institut Gustave Roussy
Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
CHR de Besancon - Hopital Saint-Jacques
Besançon, , France
Institut Bergonie
Bordeaux, , France
CHU Hopital A. Morvan
Brest, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Hospitalier Universitaire de Dijon
Dijon, , France
CHU de Grenoble - Hopital Michallon
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Hopital d'Enfants de la Timone
Marseille, , France
CHU Nord
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hopital de l'Archet CHU de Nice
Nice, , France
Institut Curie Hopital
Paris, , France
Hopital Jean Bernard
Poitiers, , France
Centre Eugene Marquis
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Centre Regional Rene Gauducheau
Saint-Herblain, , France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
Hopital des Enfants
Toulouse, , France
C.H. Bastien de Clocheville
Tours, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
Lui G, Treluyer JM, Fresneau B, Piperno-Neumann S, Gaspar N, Corradini N, Gentet JC, Marec Berard P, Laurence V, Schneider P, Entz-Werle N, Pacquement H, Millot F, Taque S, Freycon C, Lervat C, Le Deley MC, Mahier Ait Oukhatar C, Brugieres L, Le Teuff G, Bouazza N; Sarcoma Group of UNICANCER. A Pharmacokinetic and Pharmacogenetic Analysis of Osteosarcoma Patients Treated With High-Dose Methotrexate: Data From the OS2006/Sarcoma-09 Trial. J Clin Pharmacol. 2018 Dec;58(12):1541-1549. doi: 10.1002/jcph.1252. Epub 2018 May 23.
Tabone MD, Brugieres L, Piperno-Neumann S, Selva MA, Marec-Berard P, Pacquement H, Lervat C, Corradini N, Gentet JC, Couderc R, Chevance A, Mahier-Ait Oukhatar C, Entz-Werle N, Blay JY, Le Deley MC. Prognostic impact of blood and urinary angiogenic factor levels at diagnosis and during treatment in patients with osteosarcoma: a prospective study. BMC Cancer. 2017 Jun 15;17(1):419. doi: 10.1186/s12885-017-3409-z.
Piperno-Neumann S, Le Deley MC, Redini F, Pacquement H, Marec-Berard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werle N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretiere JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugieres L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17.
Other Identifiers
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UNICANCER-SARCOME-09-0603
Identifier Type: OTHER
Identifier Source: secondary_id
2006-003377-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Sarcome 09/0603
Identifier Type: -
Identifier Source: org_study_id
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