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| Name | Class |
|---|---|
| French Sarcoma Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any cancer treatment | Other | chemotherapy, surgery, radiotherapy, interventional radiology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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patients with the diagnosis of Ewing's sarcoma, osteosarcoma, chondrosarcoma,
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| Name | Affiliation | Role |
|---|---|---|
| Maud Toulmonde, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié, Comprehensive Cancer Center | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705468 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. |
| FG001 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. |
| FG002 | Ewing's Sarcoma | Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death. | Posted | Median | 95% Confidence Interval | months | 5 years |
|
5 years Serious and non-serious adverse events were not recorded for the purpose of this study.
Serious and non-serious adverse events were not recorded for the purpose of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2007 | Sep 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| BG001 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. |
| BG002 | Ewing's Sarcoma | Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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: chemotherapy, surgery, radiotherapy, interventional radiology. |
| OG002 | Ewing's Sarcoma | Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. |
|
|
| Primary | Time to Next Treatment (TNT) | time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| 172 |
| 262 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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: chemotherapy, surgery, radiotherapy, interventional radiology. | 93 | 127 | 0 | 0 | 0 | 0 |
| EG002 | Ewing's Sarcoma | Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. | 115 | 156 | 0 | 0 | 0 | 0 |
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| Male |
|