Clinical Trial

Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

Study acronym: OS2006
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2007-05-03; most recent amendment 2025-06-04.
Status change: Terminated → Active, Not Recruiting 2019-10-17
Status change: Recruiting → Terminated 2016-01-03
Trial Details
NCT Number NCT00470223
Lead Sponsor UNICANCER
Collaborators: Novartis, Chugai Pharmaceutical, National Cancer Institute, France, SFCE, Ligue contre le cancer, France
Conditions Sarcoma
Enrollment 318 participants
Start Date 2007-03
Primary Completion 2015-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-08