We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00470223
Recruitment Status : Active, not recruiting
First Posted : May 7, 2007
Last Update Posted : June 27, 2022
Sponsor:
Collaborators:
Novartis
Chugai Pharmaceutical
National Cancer Institute, France
SFCE
Ligue contre le cancer, France
Information provided by (Responsible Party):
UNICANCER

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

Show Show detailed description

Layout table for study information
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
Actual Study Start Date : March 2007
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy + zoledronic 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00470223


Locations
Show Show 37 study locations
Sponsors and Collaborators
UNICANCER
Novartis
Chugai Pharmaceutical
National Cancer Institute, France
SFCE
Ligue contre le cancer, France
Investigators
Layout table for investigator information
Study Chair: Laurence Brugieres, MD Gustave Roussy, Cancer Campus, Grand Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00470223    
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 27, 2022
Last Verified: June 2022
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:
Layout table for MeSH terms
Osteosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Zoledronic Acid
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Etoposide
Ifosfamide
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
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors