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| Name | Class |
|---|---|
| Scandinavian Sarcoma Group | OTHER |
| Cooperative Osteosarcoma Study Group | UNKNOWN |
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The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial.
In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.
Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.
All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy for Good responder | Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma |
| |
| Chemotherapy for Poor responder | Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin+cisplatin+ifosfamide | Drug | Chemotherapy for Good responder high grade osteosarcoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death) | from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Survival without progression of disease | from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients older than 40 years with highly malignant spindle cell sarcoma of bone
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Ferrari, MD | Italian Sarcoma Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooperative Osteosarcoma Study Group | Stuttgart | D-70176 | Germany | |||
| Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors |
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| Label | URL |
|---|---|
| Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years | View source |
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Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Doxorubicin+cisplatin+ifosfamide+methotrexate | Drug | Chemotherapy for Poor responder high grade osteosarcoma |
|
|
Survival without disease
| from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months |
| Metastasis-free survival | Survival without metastasis | from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months |
| Overall survival | Global patients survival evaluation after treatment | from the date of randomization until the end of the study, assessed every 3 months, up to 168 month |
| Chemotherapy toxicity | Number and grade of adverse events related to the study treatments | Every 3 weeks |
| Bologna |
| Bologna |
| 40136 |
| Italy |
| Scandinavian Sarcoma Group | Lund | SE-221 85 | Sweden |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |