BridgeMD
Treatment protocol for osteosarcomas in children, adolescents and adults including a randomized trial and biological studies
EU CTIS ID: 2024-514756-32-00
What this study is testing
Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy and surgery with or without zoledronic acid
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Low-grade osteosarcoma
- Bilirubin > 2 x upper normal value
- 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.
- Any medical abnormality incompatible with the treatments planned in this study.
- Pregnancy or breast-feeding
See the full eligibility criteria
- 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
- Low-grade osteosarcoma
- Bilirubin > 2 x upper normal value
- 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.
- 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
- Polymetastatic osteosarcoma with metastases considered a priori inoperable even after reduction with chemotherapy
- Extraosseous osteosarcoma
- Chronic disease incompatible with the protocol
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.