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

NCT ID: NCT03963531

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 545 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-05
• Study Completion Date: 2025-01-31

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.

Conditions

Metastatic Bone Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Any cancer treatment

Intervention Type: OTHER

chemotherapy, surgery, radiotherapy, interventional radiology.

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

Any cancer treatment

Intervention Type: OTHER

chemotherapy, surgery, radiotherapy, interventional radiology.

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

Any cancer treatment

Intervention Type: OTHER

chemotherapy, surgery, radiotherapy, interventional radiology.

Interventions

Any cancer treatment

chemotherapy, surgery, radiotherapy, interventional radiology.

Intervention Type: OTHER

Other Intervention Names

intervention as per recommendations

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Sarcoma Group

OTHER

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maud Toulmonde, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 40705468 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IB2019-METABONE

Identifier Type: -

Identifier Source: org_study_id