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ISRCTN
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ISRCTN61438620
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ClinicalTrials.gov identifier
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NCT00020566
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Public title
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EURO-EWING 99: European Ewing Tumour Working Initiative of National Groups
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Scientific title
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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
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Acronym
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EURO-EWING 99
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Serial number at source
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ET2000/03 (EE99)
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Study hypothesis
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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.
Please note as of 08/02/2011 the anticipated end date for this trial has been updated from 31/03/2010 to 30/03/2017.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-looking-at-treatment-for-patients-with-ewings-sarcoma-or-peripheral-primitive-neuroectodermal-tumour
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Netherlands, New Zealand, Portugal, Switzerland, United Kingdom, United States of America
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Disease/condition/study domain
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Ewing's sarcoma
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Participants - inclusion criteria
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1. Histologically confirmed Ewing's tumour of the bone or soft tissue
2. Age less than 50
3. Completed pre-treatment investigations allowing prognostic group definition
4. No previous chemotherapy
5. Informed consent
6. Normal cardiac and renal function
7. Interval between date of definitive biopsy and registration less than 45 days
8. Interval between date of definitive biopsy and start of chemotherapy less than 30 days
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/02/2001
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Anticipated end date
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30/03/2017
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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1200
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Interventions
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Three randomisations, two arms per randomisation:
Randomisation 1: vincristine, dactinomycin, and ifosfamide (VAI) versus vincristine, dactinomycin, and cyclophosphamide (VAC)
Randomisation 2 (loc): VAI versus busulfan, melphalan (Bu-Mel)
Randomisation 2 (pulm): VAI and lung radiation versus Bu-Mel (NO lung radiation)
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Primary outcome measure(s)
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1. Event-free survival
2. Overall survival
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Secondary outcome measure(s)
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1. Feasibility, toxicity, and response at one month following induction therapy
2. Feasibility and toxicity of consolidation regimens at one month following consolidation therapy
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Sources of funding
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United Kingdom Children's Cancer Study Group (UK)
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Trial website
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Publications
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2006 safety assessment results in http://www.ncbi.nlm.nih.gov/pubmed/16572419
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 207 670 4723
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Fax
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+44 (0) 207 670 4818
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Email
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Sponsor
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United Kingdom Children's Cancer Study Group (UK)
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Address
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University of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
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City/town
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Leicester
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Zip/Postcode
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LE1 6HT
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Country
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United Kingdom
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Sponsor website:
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http://www.ukccsg.org
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Date applied
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19/08/2002
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Last edited
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16/08/2011
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Date ISRCTN assigned
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19/08/2002
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