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Patterns of Care and Outcomes in Patients With Metastatic Bone Tumors (METABONE) (METABONE)

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: NCT03963531
Recruitment Status : Active, not recruiting
First Posted : May 24, 2019
Last Update Posted : March 7, 2022
Sponsor:
Collaborator:
French Sarcoma Group
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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Brief Summary:

Bone tumors make up about 3-5% of childhood cancers and less than 1% of cancers in adults. Of these, osteosarcoma (OSS) is the most commonly diagnosed primary malignant bone tumor. OSS is a primary mesenchymal malignant tumor of bone characterized by the production of osteoid or immature bone by the malignant cells. Despite its rarity, OSS is the most common primary malignancy of bone in children and adolescents, and the fifth most common malignancy among adolescents and young adults aged 15 to 19 years.

Ewing sarcoma (ES) is the second most frequent bone tumors in children and may arise also in soft tissues. This disease encompasses tumors formerly known as Askin's tumor, Peripheral Neuroectodermal Tumor (PNET) and the Ewing Sarcoma Family of Tumors (ESFT).

Chondrosarcoma are rare sarcoma reputed chemorefractory in the non-operable setting and for which little is known in terms of palliative management with systemic treatments.

Despite adequate loco-regional treatment, up to 40% of patients with sarcoma, soft tissue or bone, will develop metastatic disease. When metastases are detected, the standard of care is based on palliative chemotherapy with a median survival in this setting of only 18 months.

A slight improvement has been obtained over years thank to registration of a couple of drugs such as Trabectedin and Pazopanib, the first antiangiogenic registered for soft tissue sarcoma patients. Pazopanib is routinely prescribed worldwide after failure of first line chemotherapy in soft tissue sarcoma. However, bone tumors have not benefited from these small advances yet and treatment still rely on chemotherapy combining doxorubicine cisplatinum and ifosfamide. There is no standard in relapse and palliative settings, and after failure of these agents the survival is very poor. Bone sarcomas are therefore tumors with very little available data and low level of evidence on palliative systemic treatments in clinical trials and in the real life setting.

The primary objective of the METABONE study is to conduct a retrospective descriptive analysis of clinic-biological profiles, patterns of care and modalities of treatment for a set of patients with malignant bone tumors in a real-life national setting.


Condition or disease Intervention/treatment
Metastatic Bone Tumor Other: chemotherapy, surgery, radiotherapy, interventional radiology.

Study Design
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Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patterns of Care and Outcomes of Patients With METAstatic BONE Tumors in a Real-life Setting
Actual Study Start Date : January 2007
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Groups and Cohorts
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Intervention Details:
  • Other: chemotherapy, surgery, radiotherapy, interventional radiology.
    Other Name: intervention as per recommendations

Outcome Measures
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Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 2 years ]
    Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.

  2. Time to next treatment (TNT) [ Time Frame: 2 years ]
    time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with the diagnosis of Ewing's sarcoma, osteosarcoma, chondrosarcoma,
Criteria

Inclusion Criteria:

  • Patients of all ages
  • Informed consent obtained for inclusion in the databases
  • Histology of Ewing's sarcoma type, osteosarcoma, chondrosarcoma
  • Diagnostic between 2007 and 2016
Contacts and Locations
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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): NCT03963531


Locations
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France
Institut Bergonié, Comprehensive Cancer Center
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
French Sarcoma Group
Investigators
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Principal Investigator: Maud Toulmonde, MD Institut Bergonié
More Information
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03963531    
Other Study ID Numbers: IB2019-METABONE
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasm Metastasis
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
 Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes