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Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma

NCT00003937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2014-08-05

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. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma.

Conditions

  • Cardiac Toxicity
  • Sarcoma

Interventions

DRUG

cisplatin

DRUG

dexrazoxane hydrochloride

DRUG

doxorubicin hydrochloride

DRUG

etoposide

DRUG

ifosfamide

DRUG

methotrexate

PROCEDURE

conventional surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Cindy Schwartz, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Primary Completion
2004-03-31
Completion
2008-06-30

Countries

  • United States
  • Australia
  • Canada
  • Netherlands
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00003937 on ClinicalTrials.gov