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Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

NCT00470223 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-06-08

No results posted yet for this 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.

Conditions

  • Sarcoma

Interventions

DRUG

cisplatin

DRUG

doxorubicin hydrochloride

DRUG

etoposide

DRUG

ifosfamide

DRUG

methotrexate

DRUG

zoledronic acid

PROCEDURE

conventional surgery

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • SFCE

    collaborator UNKNOWN

  • Ligue contre le cancer, France

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Laurence Brugieres, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2015-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470223 on ClinicalTrials.gov