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Trial record 1 of 1 for:    NCT00020566
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

This study is currently recruiting participants.
Verified December 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
European Organisation for Research and Treatment of Cancer - EORTC
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
Swiss Group for Clinical Cancer Research
EBMT Solid Tumors Working Party
Children's Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020566
First received: July 11, 2001
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.


Condition Intervention Phase
Sarcoma
 Biological: dactinomycin
Drug: busulfan
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: melphalan
Drug: vincristine sulfate
Procedure: autologous hematopoietic stem cell transplantation
Procedure: conventional surgery
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility, toxicity, and response at 1 month following induction therapy [ Designated as safety issue: Yes ]
  • Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: February 2001
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.
 Biological: dactinomycin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it
Experimental: Group 2, arm I
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
 Biological: dactinomycin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it
Experimental: Group 2, arm II
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.
 Biological: dactinomycin
Given IV
Drug: busulfan
Given orally and IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Drug: melphalan
Given orally and IV
Drug: vincristine sulfate
Given IV
Procedure: autologous hematopoietic stem cell transplantation
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed tumor of the Ewing's family of bone or soft tissue

    • Ewing's sarcoma
    • Peripheral primitive neuroectodermal tumor

  • Disease meeting one of the following criteria:

    • Resectable localized disease (tumor volume less than 200 mL)
    • Localized disease previously resected at diagnosis
    • Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed
    • Localized disease with early radiotherapy required
    • Pulmonary and/or pleural metastases only
    • Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
  • No more than 45 days since definitive biopsy

PATIENT CHARACTERISTICS:

Age:

  • Under 50

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Renal function normal
  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • Normal cardiac function
  • Fractional shortening at least 29%
  • Ejection fraction at least 40%

Other:

  • No medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020566

  Show 104 Study Locations
Sponsors and Collaborators
University Hospitals, Leicester
National Cancer Institute (NCI)
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
European Organisation for Research and Treatment of Cancer - EORTC
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
Swiss Group for Clinical Cancer Research
EBMT Solid Tumors Working Party
Children's Oncology Group
Investigators
Study Chair: Alan W. Craft, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Study Chair: Ian J. Lewis, MD Leeds Cancer Centre at St. James's University Hospital
Study Chair: Odile Oberlin, MD Institut Gustave Roussy
Investigator: Ian R. Judson, MA, MD, FRCP Institute of Cancer Research, United Kingdom
Study Chair: Heribert F. Juergens, MD Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Study Chair: Helmut Gadner, MD, FRCPG St. Anna Kinderkrebsforschung
Study Chair: G. Ulrich Exner, MD Balgrist Universitaetsklinik
Study Chair: Ruth Ladenstein, MD St. Anna Kinderkrebsforschung
Study Chair: Douglas Hawkins, MD Seattle Children's Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00020566     History of Changes
Other Study ID Numbers: CDR0000068608, EURO-EWING-INTERGROUP-EE99, EBMT-INTERGROUP-EE99, EORTC-62981, GPOH-AUSTRIA-INTERGROUP-EE99, GPOH-GERMANY-INTERGROUP-EE99, SFOP-INTERGROUP-EE99, SWS-SAKK-INTERGROUP-EE99, CCLG-INTERGROUP-EE99, COG-AEWS0331, EU-20213
Study First Received: July 11, 2001
Last Updated: December 14, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Dactinomycin
Doxorubicin
Isophosphamide mustard
Busulfan
Etoposide
Ifosfamide
Melphalan
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013