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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
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)
ClinicalTrials.gov Identifier:
NCT00334854
First received: June 7, 2006
Last updated: August 9, 2013
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Local relapse-free survival [ Designated as safety issue: No ]
  • Metastases-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease) [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2006
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior cancer treatment except primary surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334854

Locations
Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
Clinique de l'Esperance
Montegnee, Belgium, 4420
Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
France
Institut Curie Hopital
Paris, France, 75248
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-75185
Switzerland
University Children's Hospital
Zurich, Switzerland, CH-8032
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B16 8ET
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
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
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00334854     History of Changes
Other Study ID Numbers: CCLG-EPSSG-NRSTS-2005  CDR0000482277  EU-20620  EUDRACT-2005-001139-31  UKCCSG-CTA-21275/0215/001/0001  CCLG-EpSSG-STS-2006-03 
Study First Received: June 7, 2006
Last Updated: August 9, 2013
Health Authority: Unspecified

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
chondrosarcoma

Additional relevant MeSH terms:
Sarcoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Histiocytoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Doxorubicin
Liposomal doxorubicin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on December 09, 2016