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

This study has been terminated.
(IDMC decision upon interim efficacy analysis)
Sponsor:
Collaborators:
Novartis
Chugai Pharmaceutical
National Cancer Institute, France
SFCE
Ligue contre le cancer, France
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00470223
First received: May 3, 2007
Last updated: June 21, 2016
Last verified: June 2016
  Purpose

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 Intervention Phase
Sarcoma
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: methotrexate
Drug: zoledronic acid
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Percentage of good responders [ Time Frame: at the time of the surgery ] [ Designated as safety issue: No ]
  • Short term and long term toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: March 2007
Estimated Study Completion Date: April 2025
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470223

Locations
France
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
UNICANCER
Novartis
Chugai Pharmaceutical
National Cancer Institute, France
SFCE
Ligue contre le cancer, France
Investigators
Study Chair: Laurence Brugieres, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00470223     History of Changes
Other Study ID Numbers: Sarcome 09/0603  UNICANCER-SARCOME-09-0603  2006-003377-27 
Study First Received: May 3, 2007
Last Updated: June 21, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Ethics Committee
Individual Participant Data  
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:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Methotrexate
Doxorubicin
Etoposide
Liposomal doxorubicin
Ifosfamide
Zoledronic acid
Diphosphonates
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 21, 2016