Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

NCT00379457 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-08-12

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. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

dactinomycin

DRUG

doxorubicin hydrochloride

DRUG

etoposide

DRUG

ifosfamide

DRUG

topotecan hydrochloride

DRUG

vincristine sulfate

DRUG

vinorelbine tartrate

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • Italian Association for Pediatric Hematology Oncology

    collaborator OTHER
  • Children's Cancer and Leukaemia Group

    collaborator OTHER
  • Dutch Childhood Oncology Group

    collaborator OTHER
  • European Paediatric Soft Tissue Sarcoma Study Group

    lead OTHER

Principal Investigators

  • Gianni Bisogno, MD · Azienda Ospedaliera di Padova

  • Meriel Jenney, MD · Childrens Hospital for Wales

  • Hans Merks, MD, PhD · Dutch Childhood Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-05-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Ireland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT00379457 on ClinicalTrials.gov