NCT03963531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2008

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

16.1 years

First QC Date

May 23, 2019

Results QC Date

August 22, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall Survival (OS)

    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 from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first

    5 years

Study Arms (3)

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

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

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

Interventions

chemotherapy, surgery, radiotherapy, interventional radiology.

Also known as: intervention as per recommendations
Metastatic Ewing's sarcomaMetastatic OsteosarcomaMetastatic chondrosarcoma

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients aged \>= 12 years
  • Histology of Ewing's sarcoma type, osteosarcoma, chondrosarcoma
  • Diagnostic between 2008 and 2018

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, 33076, France

Location

Related Publications (1)

  • Ducrot C, Dinart D, Reich M, Piffoux M, Bonneau M, Larroquette M, Nannini S, Berchoud J, Bellio H, Cherrier G, Narciso B, Le Cesne A, Bompas E, Gantzer J, Valentin T, Anract P, de Percin S, Boudou-Rouquette P, de Pinieux G, Gouin F, Brahmi M, Bellera C, Toulmonde M. Metastatic chondrosarcoma, patterns of care, and outcomes of patients in a real-life national setting over a decade. Int J Cancer. 2025 Dec 1;157(11):2325-2333. doi: 10.1002/ijc.70023. Epub 2025 Jul 24.

    PMID: 40705468BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Simone Mathoulin-Pélissier, Director of Clinical Trials unit
Organization
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Study Officials

  • Maud Toulmonde, MD

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 24, 2019

Study Start

January 5, 2008

Primary Completion

January 31, 2024

Study Completion

January 31, 2025

Last Updated

December 10, 2025

Results First Posted

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations