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

November 24, 2025 updated by: Institut Bergonié

Patterns of Care and Outcomes of Patients With METAstatic BONE Tumors in a Real-life Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié, Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with the diagnosis of Ewing's sarcoma, osteosarcoma, chondrosarcoma,

Description

Inclusion Criteria:

  • Patients aged >= 12 years
  • Informed consent obtained for inclusion in the databases
  • Histology of Ewing's sarcoma type, osteosarcoma, chondrosarcoma
  • Diagnostic between 2008 and 2018

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastatic Osteosarcoma
Patients aged ≥ 12 years 1/ with a diagnosis of osteosarcoma made by an expert pathologist from one of the French network centers (RESOS), 2/ with an initial diagnosis made from 2008 to 2018, 3/ with a metastatic disease (either synchronous or metachronous), 4/ treated in one of the 11 participating national reference centers designated by the French National Cancer Institute for the management of bone sarcomas
Other: Any cancer treatment
chemotherapy, surgery, radiotherapy, interventional radiology.
Other Names:
  • intervention as per recommendations
Metastatic chondrosarcoma
Patients aged ≥12 years (1) with a diagnosis of chondrosarcoma made by an expert pathologist from one of the French network centers, (2) with an initial diagnosis made from 2008 to 2018, (3) with a metastatic disease (either synchronous or metachronous), (4) treated in one of the nine participating national reference centers designated by the French National Cancer Institute for the management of bone sarcomas
Other: Any cancer treatment
chemotherapy, surgery, radiotherapy, interventional radiology.
Other Names:
  • intervention as per recommendations
Metastatic Ewing's sarcoma
Patients aged ≥12 years 1/ with a diagnosis of Ewing sarcoma made by an expert pathologist from one of the French network centers (RESOS), 2/ with a diagnosis made from 2008 to 2018, 3/ with a metastatic disease (either synchronous or metachronous ), 4/ treated in one of the 10 national reference centers designated by the French National Cancer Institute for the management of bone sarcomas
Other: Any cancer treatment
chemotherapy, surgery, radiotherapy, interventional radiology.
Other Names:
  • intervention as per recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 5 years
Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
5 years
Time to Next Treatment (TNT)
Time Frame: 5 years
time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

French Sarcoma Group

Investigators

  • Principal Investigator: Maud Toulmonde, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2008

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2019-METABONE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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