Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma (NCT00470223) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma
France318 participantsStarted 2007-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.
Who can participate
Age range
5 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Histologically confirmed high-grade osteosarcoma
* Bilirubin ≤ 2 times upper limit of normal
* No medical condition that would preclude study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Shortening fraction ≥ 28%
* LVEF ≥ 50%
* Glomerular filtration rate ≥ 70mL/min
* No recent dental problem, including infection, traumatization, or surgery
Exclusion Criteria
* Low-grade osteosarcoma
* Small cell osteosarcoma
* Maxillary osteosarcoma
* Primary resected osteosarcoma
* Osteosarcoma with multiple metastases for which complete removal is not feasible even after shrinkage with chemotherapy
* Extra-osseous osteosarcoma
* Any prior osteonecrosis of the maxilla
* No prior chemotherapy or radiotherapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.