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Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma

NCT00002539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2012-09-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

filgrastim

DRUG

cisplatin

DRUG

doxorubicin hydrochloride

PROCEDURE

conventional surgery

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Marianne A. Nooij, MD · Leiden University Medical Center

  • Ian J. Lewis, MD · Leeds Cancer Centre at St. James's University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-08-31
Primary Completion
2002-10-31

Countries

  • Belgium
  • Denmark
  • France
  • Netherlands
  • Portugal
  • Saudi Arabia
  • Slovenia
  • United Kingdom

Study Locations

More Related Trials

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 NCT00002539 on ClinicalTrials.gov