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).
Study Type
OBSERVATIONAL
Enrollment
100
Chemotherapy for Good responder high grade osteosarcoma
Chemotherapy for Poor responder high grade osteosarcoma
Cooperative Osteosarcoma Study Group
Stuttgart, Germany
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Bologna, Italy
Scandinavian Sarcoma Group
Lund, Sweden
Event-free survival
Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)
Time frame: 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.
Progression-free survival
Survival without progression of disease
Time frame: 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
Survival without disease
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Every 3 weeks
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