Metastatic Bone TumorMETABONENCT03963531
Patterns of Care and Outcomes in Patients With Metastatic Bone Tumors (METABONE)
An observational study of Metastatic Bone Tumor, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Metastatic Bone Tumor
- What is being tested?
- Any cancer treatment
- How many people
- 545 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2008to 31 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with the diagnosis of Ewing's sarcoma, osteosarcoma, chondrosarcoma,
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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
- Being tested
- Any cancer treatment
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any cancer treatmentOther
Also called intervention as per recommendations
chemotherapy, surgery, radiotherapy, interventional radiology.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Any cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start5 Jan 2008
- Primary completion31 Jan 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Bone TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- French Sarcoma Group
- Responsible party
- Sponsor
- Investigators
- Maud Toulmonde, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963531
- Sponsor's protocol ID
- IB2019-METABONE
- Acronym
- METABONE
- Status last verified
- Nov 2025
- First submitted
- 23 May 2019
- Last updated
- 10 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40705468
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Care and Outcomes of Patients With METAstatic BONE Tumors in a Real-life Setting
- ClinicalTrials.gov ID
- NCT03963531
- Acronym / sponsor ID
- METABONE / IB2019-METABONE
- Conditions
- Metastatic Bone Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- French Sarcoma Group
- Study start
- 5 Jan 2008 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 10 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic Osteosarcoma | – | Other: Any cancer treatmentPatients 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 |
| Metastatic chondrosarcoma | – | Other: Any cancer treatmentPatients 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 |
| Metastatic Ewing's sarcoma | – | Other: Any cancer treatmentPatients 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with the diagnosis of Ewing's sarcoma, osteosarcoma, chondrosarcoma,
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any cancer treatmentAlso: intervention as per recommendationschemotherapy, surgery, radiotherapy, interventional radiology. | Other | Metastatic Ewing's sarcoma, Metastatic Osteosarcoma, Metastatic chondrosarcoma |
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40705468Ducrot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maud Toulmonde, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Bone Tumor, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.