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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00334854
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 8, 2006
Last Update Posted : August 12, 2013
Italian Association for Pediatric Hematology Oncology
Cooperative Weichteilsarkom Studie
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Study Start Date : March 2006
Estimated Primary Completion Date : May 2010

Primary Outcome Measures :
  1. Event-free survival
  2. Local relapse-free survival
  3. Metastases-free survival
  4. Overall survival
  5. Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed synovial sarcoma or adult-type soft-tissue sarcoma

    • Adult-type soft tissue sarcoma includes any of the following:

      • Fibrosarcoma (adult-type)

        • No infantile fibrosarcoma
      • Malignant peripheral nerve sheath tumor

        • Malignant schwannoma
        • Neurofibrosarcoma
      • Epithelioid sarcoma
      • Leiomyosarcoma
      • Clear cell sarcoma
      • Liposarcoma
      • Alveolar soft-part sarcoma
      • Malignant fibrous histiocytoma
      • Hemangiopericytoma
      • Angiosarcoma
      • Dermatofibrosarcoma protuberans
      • Mesenchymal chondrosarcoma
  • No borderline tumors (e.g., hemangioendothelioma)
  • No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor)
  • Post-irradiation soft-part sarcomas allowed
  • Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy)
  • No evidence of metastatic disease

    • Involved locoregional lymph nodes are allowed


  • No prior malignancy
  • No pre-existing illness precluding study treatment*
  • Normal renal function (nephrotoxicity grade 0-1)*
  • No history of cardiac disease*
  • Normal shortening fraction (> 28%)*
  • Ejection fraction > 47%* NOTE: * For patients who require adjuvant chemotherapy


  • No prior cancer treatment except primary surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00334854

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St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Ruth Ladenstein, MD    43-1-404-700      
Clinique de l'Esperance Recruiting
Montegnee, Belgium, 4420
Contact: Nadine Francotte, MD    32-4-224-9111   
Rigshospitalet - Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Catherine Rechnitzer, MD, PhD    45-3545-1368   
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Daniel Orbach, MD    33-14-432-4550      
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Anne O'Meara, MD    353-409-6659      
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Soledad Gallego, MD, PhD    34-93-489-3090   
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-75185
Contact: Gustaf Ljungman, MD    46-18-611-5586      
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD    41-44-266-7823      
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B16 8ET
Contact: David Hobin, MD    44-121-454-4851      
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: M. C. G. Stevens, MD    44-117-342-0205   
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Denise Williams, MD    44-1223-256-298      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD    44-113-206-4984   
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD    44-116-258-5309   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD    44-20-7380-9300 ext. 9950      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Julia Chisholm, MD    44-20-7829-7924      
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227   
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD    44-191-282-4101   
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH    44-115-924-9924 ext. 63394   
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD    44-186-522-1066      
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH    44-114-271-7366   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Kathy Pritchard-Jones, MD    44-20-8661-3452 ext 3498      
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD    44-289-063-3631   
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Derek King, MD    44-1224-681-818      
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD    44-29-2074-2285   
Sponsors and Collaborators
European Paediatric Soft Tissue Sarcoma Study Group
Italian Association for Pediatric Hematology Oncology
Cooperative Weichteilsarkom Studie
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
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Study Chair: Andrea Ferrari, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Chair: Modesto Carli, MD Azienda Ospedaliera di Padova
Study Chair: Joern Treuner, MD Olgahospital
Study Chair: Bernadette Brennan, MD Royal Manchester Children's Hospital
Study Chair: Max Van Noesel, MD, PhD Erasmus MC - Sophia Children's Hospital

Layout table for additonal information Identifier: NCT00334854     History of Changes
Other Study ID Numbers: CCLG-EPSSG-NRSTS-2005
CDR0000482277 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
childhood synovial sarcoma
nonmetastatic childhood soft tissue sarcoma
childhood alveolar soft-part sarcoma
childhood angiosarcoma
childhood epithelioid sarcoma
childhood fibrosarcoma
childhood leiomyosarcoma
childhood liposarcoma
childhood neurofibrosarcoma
localized childhood malignant fibrous histiocytoma of bone
childhood malignant hemangiopericytoma
dermatofibrosarcoma protuberans
Additional relevant MeSH terms:
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Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Liposomal doxorubicin
Isophosphamide mustard
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents