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Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

NCT00334854 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-08-12

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.

Conditions

  • Childhood Malignant Fibrous Histiocytoma of Bone
  • Sarcoma

Interventions

DRUG

doxorubicin hydrochloride

DRUG

ifosfamide

PROCEDURE

adjuvant therapy

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • Italian Association for Pediatric Hematology Oncology

    collaborator OTHER

  • Cooperative Weichteilsarkom Studie

    collaborator UNKNOWN

  • 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

  • Andrea Ferrari, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Modesto Carli, MD · Azienda Ospedaliera di Padova

  • Joern Treuner, MD · Olgahospital

  • Bernadette Brennan, MD · Royal Manchester Children's Hospital

  • Max Van Noesel, MD, PhD · Erasmus MC-Sophia Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-05-31

Countries

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

Study Locations

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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 NCT00334854 on ClinicalTrials.gov