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Trial record 11 of 13 for:    "Bone Osteosarcoma" | "Bone Density Conservation Agents"

Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma (OS2006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470223
Recruitment Status : Terminated (IDMC decision upon interim efficacy analysis)
First Posted : May 7, 2007
Last Update Posted : June 22, 2016
Chugai Pharmaceutical
National Cancer Institute, France
Ligue contre le cancer, France
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.

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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: methotrexate Drug: zoledronic acid Procedure: conventional surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant
Study Start Date : March 2007
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Chemotherapy + zoledronicc acid Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: methotrexate
Drug: zoledronic acid
Procedure: conventional surgery
Active Comparator: chemotherapy Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: methotrexate
Procedure: conventional surgery

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 10 years ]
  2. Percentage of good responders [ Time Frame: at the time of the surgery ]
  3. Short term and long term toxicity [ Time Frame: 10 years ]
  4. Quality of life [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Histologically confirmed high-grade osteosarcoma
  • 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

  • Low-grade osteosarcoma
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470223

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Centre Paul Papin
Angers, France, 49036
Institut Gustave Roussy
Angers, France, 49036
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
CHR de Besancon - Hopital Saint-Jacques
Besancon, France, 25030
Institut Bergonie
Bordeaux, France, 33076
CHU Hopital A. Morvan
Brest, France, 29609
CHU de Caen
Caen, France, 14033
Centre Regional Francois Baclesse
Caen, France, 14076
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, France, 63003
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21079
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Hopital d'Enfants de la Timone
Marseille, France, 13385
CHU Nord
Marseille, France, 13915
Hopital Arnaud de Villeneuve
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hopital de l'Archet CHU de Nice
Nice, France, F-06202
Institut Curie Hopital
Paris, France, 75248
Hopital Jean Bernard
Poitiers, France, 86021
Centre Eugene Marquis
Rennes, France, 35042
Hopital Charles Nicolle
Rouen, France, 76031
Centre Henri Becquerel
Rouen, France, 76038
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
Hopital des Enfants
Toulouse, France, 31059
C.H. Bastien de Clocheville
Tours, France, 3700
CHRU de Tours - Hopital Trousseau
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Chugai Pharmaceutical
National Cancer Institute, France
Ligue contre le cancer, France
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Study Chair: Laurence Brugieres, MD Gustave Roussy, Cancer Campus, Grand Paris

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: UNICANCER Identifier: NCT00470223     History of Changes
Other Study ID Numbers: Sarcome 09/0603
UNICANCER-SARCOME-09-0603 ( Other Identifier: UNICANCER )
2006-003377-27 ( EudraCT Number )
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients.
Keywords provided by UNICANCER:
localized osteosarcoma
metastatic osteosarcoma
Additional relevant MeSH terms:
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Bone Density Conservation Agents
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Zoledronic Acid
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors