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Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized Ewing's Sarcoma

NCT00334867 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-06-28

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, and topotecan, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and topotecan to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed localized Ewing's sarcoma.

Conditions

  • Sarcoma

Interventions

DRUG

cyclophosphamide

Given IV

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

DRUG

topotecan hydrochloride

Given IV

DRUG

vincristine sulfate

Given IV

PROCEDURE

conventional surgery

Patients undergo surgery in week 18

PROCEDURE

radiation therapy

Patients undergo radiation therapy in week 19

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Mason Bond, MD · Children's & Women's Hospital of British Columbia

  • Leo Mascarenhas, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-01-31

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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 NCT00334867 on ClinicalTrials.gov