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EURO-EWING 99: European Ewing Tumour Working Initiative of National Groups
Source of recordUK Trials
ISRCTNISRCTN61438620
Date ISRCTN assigned19/08/2002
Local reference number(s)ET2000/03 (EE99)
Public titleEURO-EWING 99: European Ewing Tumour Working Initiative of National Groups
Scientific titleCombination chemotherapy with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma
AcronymEURO-EWING 99
Disease/condition/study domainEwing's sarcoma
Study hypothesisThis 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.
Design/methodologyRandomised controlled trial
Research ethics reviewNot provided at time of registration
Countries of trialAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Netherlands, New Zealand, Portugal, Switzerland, United Kingdom, United States of America,
Participants - inclusion criteria1. 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
Participants - exclusion criteriaDoes not comply with above inclusion criteria
Patient information material
Anticipated start date01/02/2001
Anticipated end date31/03/2010
Status of trialOngoing
Target number of participants1200
InterventionsThree 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)
Primary outcome measure(s)1. Event-free survival
2. Overall survival
Secondary outcome measure(s)1. Feasibility, toxicity, and response at one month following induction therapy
2. Feasibility and toxicity of consolidation regimens at one month following consolidation therapy
PublicationsResults in http://www.ncbi.nlm.nih.gov/pubmed/16572419
Sources of fundingUnited Kingdom Children's Cancer Study Group (UK)
Sponsor nameUnited Kingdom Children's Cancer Study Group (UK)
Sponsor detailsUniversity of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
Leicester
United Kingdom
LE1 6HT
Sponsor websitehttp://www.ukccsg.org
Contact nameDr - -
Contact detailsUKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA
Contact telephone+44 (0) 20 7670 4723
Contact fax+44 (0) 20 7670 4818
Contact emailregister@ctu.mrc.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN61438620
Date last extracted from ISRCTN register17/04/2008
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