Treatment protocol for osteosarcomas in children, adolescents and adults including a randomized trial and biological studies

Prior treatment

• Polymetastatic osteosarcoma with metastases considered a priori inoperable even after reduction with chemotherapy

Other illness

• Current or recent dental problem (< 6 weeks) including any severe infection of the teeth or jaw (mandible and maxilla), dental trauma, dental or stomatological surgery (implants). Simple dental treatment is not a contraindication. A delay of 3 weeks is required between dental avulsion and the administration of Zometa®.
• History of osteonecrosis of the jawbone or exposure of bone or delayed healing after dental surgery.
• Chronic disease incompatible with the protocol

Lab values

• Bilirubin > 2 x upper normal value
• Shortening fraction less than 28% or isotopic or echographic LVEF < 50% before treatment for patients to be treated according to the API-AI protocol
• Calculated creatinine clearance < 70 mL/min/1.73 m².

Other

• Low-grade osteosarcoma
• Any medical abnormality incompatible with the treatments planned in this study.
• Pregnancy or breast-feeding
• Patients who, for family, social, geographical or psychological reasons, cannot be monitored regularly.
• Small cell osteosarcoma
• Maxillary osteosarcoma (due to the risk of osteonecrosis of the maxilla associated with biphosphonates)
• Osteosarcoma operated on from the outset
• Extraosseous osteosarcoma

• Patient with histologically proven high-grade osteosarcoma
• 5 years ≤ Age ≤ 50 years
• No contraindication to the treatments envisaged
• Not previously treated with chemo or radiotherapy for this tumour or another cancer
• Have signed the informed consent form. For unemancipated minors, authorisation will be given by the holders of parental authority. This authorisation may be given by only one of the holders of parental authority if the other holder is unable to give his or her authorisation within a timeframe compatible with the methodological requirements for carrying out the research. Minors will receive information adapted to their capacity for understanding.
• For which long-term follow-up is possible
• and declared to the registration centre as soon as consent has been obtained, at the latest on the 3rd day of the first course of chemotherapy.
• Effective contraception for women of childbearing age
• Membership of a social security scheme