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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00020566
Registration number
NCT00020566
Ethics application status
Date submitted
11/07/2001
Date registered
27/01/2003
Date last updated
24/06/2014
Titles & IDs
Public title
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
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Scientific title
European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)
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Secondary ID [1]
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EURO-EWING-INTERGROUP-EE99
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Secondary ID [2]
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CDR0000068608
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - dactinomycin
Treatment: Drugs - busulfan
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - melphalan
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - autologous hematopoietic stem cell transplantation
Treatment: Surgery - conventional surgery
Treatment: Other - radiation therapy
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.
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.
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.
Treatment: Other: dactinomycin
Given IV
Treatment: Drugs: busulfan
Given orally and IV
Treatment: Drugs: doxorubicin hydrochloride
Given IV
Treatment: Drugs: etoposide
Given IV
Treatment: Drugs: ifosfamide
Given IV
Treatment: Drugs: melphalan
Given orally and IV
Treatment: Drugs: vincristine sulfate
Given IV
Treatment: Surgery: autologous hematopoietic stem cell transplantation
Given IV
Treatment: Surgery: conventional surgery
Given to patients deemed to require it
Treatment: Other: radiation therapy
Given to patients deemed to require it
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Intervention code [1]
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Treatment: Other
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Treatment: Drugs
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Treatment: Surgery
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Outcomes
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Secondary outcome [1]
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Feasibility, toxicity, and response at 1 month following induction therapy
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Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy
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Eligibility
Key inclusion 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
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Minimum age
No limit
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Maximum age
49
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Blinded (masking used)
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2001
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Actual
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Sample size
Target
1200
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Accrual to date
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Final
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Recruitment in Australia
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NSW,QLD,SA,WA
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Princess Margaret Hospital for Children - Perth
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Leicester
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National Cancer Institute (NCI)
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Children's Cancer and Leukaemia Group
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Societe Francaise Oncologie Pediatrique
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European Organisation for Research and Treatment of Cancer - EORTC
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German Society for Pediatric Oncology and Hematology GPOH gGmbH
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Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
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Swiss Group for Clinical Cancer Research
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EBMT Solid Tumors Working Party
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00020566
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Trial related presentations / publications
Ladenstein R, Potschger U, Le Deley MC, Whelan J, Paulussen M, Oberlin O, van den Berg H, Dirksen U, Hjorth L, Michon J, Lewis I, Craft A, Jurgens H. Primary disseminated multifocal Ewing sarcoma: results of the Euro-EWING 99 trial. J Clin Oncol. 2010 Jul 10;28(20):3284-91. doi: 10.1200/JCO.2009.22.9864. Epub 2010 Jun 14. Le Deley MC, Delattre O, Schaefer KL, Burchill SA, Koehler G, Hogendoorn PC, Lion T, Poremba C, Marandet J, Ballet S, Pierron G, Brownhill SC, Nesslbock M, Ranft A, Dirksen U, Oberlin O, Lewis IJ, Craft AW, Jurgens H, Kovar H. Impact of EWS-ETS fusion type on disease progression in Ewing's sarcoma/peripheral primitive neuroectodermal tumor: prospective results from the cooperative Euro-E.W.I.N.G. 99 trial. J Clin Oncol. 2010 Apr 20;28(12):1982-8. doi: 10.1200/JCO.2009.23.3585. Epub 2010 Mar 22. Juergens C, Weston C, Lewis I, Whelan J, Paulussen M, Oberlin O, Michon J, Zoubek A, Juergens H, Craft A. Safety assessment of intensive induction with vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) in the treatment of Ewing tumors in the EURO-E.W.I.N.G. 99 clinical trial. Pediatr Blood Cancer. 2006 Jul;47(1):22-9. doi: 10.1002/pbc.20820. Dirksen U, Brennan B, Le Deley MC, Cozic N, van den Berg H, Bhadri V, Brichard B, Claude L, Craft A, Amler S, Gaspar N, Gelderblom H, Goldsby R, Gorlick R, Grier HE, Guinbretiere JM, Hauser P, Hjorth L, Janeway K, Juergens H, Judson I, Krailo M, Kruseova J, Kuehne T, Ladenstein R, Lervat C, Lessnick SL, Lewis I, Linassier C, Marec-Berard P, Marina N, Morland B, Pacquement H, Paulussen M, Randall RL, Ranft A, Le Teuff G, Wheatley K, Whelan J, Womer R, Oberlin O, Hawkins DS; Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators. High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008. J Clin Oncol. 2019 Dec 1;37(34):3192-3202. doi: 10.1200/JCO.19.00915. Epub 2019 Sep 25. Le Deley MC, Paulussen M, Lewis I, Brennan B, Ranft A, Whelan J, Le Teuff G, Michon J, Ladenstein R, Marec-Berard P, van den Berg H, Hjorth L, Wheatley K, Judson I, Juergens H, Craft A, Oberlin O, Dirksen U. Cyclophosphamide compared with ifosfamide in consolidation treatment of standard-risk Ewing sarcoma: results of the randomized noninferiority Euro-EWING99-R1 trial. J Clin Oncol. 2014 Aug 10;32(23):2440-8. doi: 10.1200/JCO.2013.54.4833. Epub 2014 Jun 30.
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Public notes
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Contacts
Principal investigator
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Alan W. Craft, MD
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Sir James Spence Institute of Child Health at Royal Victoria Infirmary
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Ladenstein R, Potschger U, Le Deley MC, Whelan J, ...
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Journal
Le Deley MC, Delattre O, Schaefer KL, Burchill SA,...
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Juergens C, Weston C, Lewis I, Whelan J, Paulussen...
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Results not provided in
https://clinicaltrials.gov/study/NCT00020566
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