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

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ClinicalTrials.gov 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
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)

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

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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)


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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00334854


Locations
Show Show 28 study locations
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
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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
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ClinicalTrials.gov Identifier: NCT00334854    
Other Study ID Numbers: CCLG-EPSSG-NRSTS-2005
CDR0000482277 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20620
EUDRACT-2005-001139-31
UKCCSG-CTA-21275/0215/001/0001
CCLG-EpSSG-STS-2006-03
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
chondrosarcoma
Additional relevant MeSH terms:
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Sarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents