Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

NCT00470223 · tracked via the Priya Life Science France tracker

Sponsor

UNICANCER

Phase

Phase 3

Started

2007-03

Last updated

2025-06-08

Condition(s) studied

Sarcoma

Investigational drug(s) / intervention(s)

cisplatin →doxorubicin hydrochloride →etoposide →ifosfamide →methotrexate →zoledronic acid →conventional surgery

Study 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.

Eligibility

Sex

ALL

Min age

5 Years

Max age

50 Years

Healthy volunteers

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

Primary outcome measure(s)

Event-free survival — 3 years

Trial sites (37)

Facility	City	Region
Centre Paul Papin	Angers	France
Institut Gustave Roussy	Angers	France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besançon	France
CHR de Besancon - Hopital Saint-Jacques	Besançon	France
Institut Bergonie	Bordeaux	France
CHU Hopital A. Morvan	Brest	France
CHU de Caen	Caen	France
Centre Regional Francois Baclesse	Caen	France
CHR Clermont Ferrand, Hotel Dieu	Clermont-Ferrand	France
Centre Jean Perrin	Clermont-Ferrand	France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire de Dijon	Dijon	France
CHU de Grenoble - Hopital Michallon	Grenoble	France
Centre Oscar Lambret	Lille	France
Centre Leon Berard	Lyon	France
Hopital Edouard Herriot - Lyon	Lyon	France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille	France
CHU de la Timone	Marseille	France
Hopital d'Enfants de la Timone	Marseille	France
CHU Nord	Marseille	France
Hopital Arnaud de Villeneuve	Montpellier	France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France
Centre Antoine Lacassagne	Nice	France
Hopital de l'Archet CHU de Nice	Nice	France
Institut Curie Hopital	Paris	France
Hopital Jean Bernard	Poitiers	France
Centre Eugene Marquis	Rennes	France
Hopital Charles Nicolle	Rouen	France
Centre Henri Becquerel	Rouen	France
Centre Regional Rene Gauducheau	Saint-Herblain	France
Institut de Cancerologie de la Loire	Saint-Priest-en-Jarez	France
Hopitaux Universitaire de Strasbourg	Strasbourg	France
Hopital Universitaire Hautepierre	Strasbourg	France
Hopital des Enfants	Toulouse	France
C.H. Bastien de Clocheville	Tours	France
CHRU de Tours - Hopital Trousseau	Tours	France
Centre Alexis Vautrin	Vandœuvre-lès-Nancy	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00470223 on ClinicalTrials.gov ↗ ← All trials in France