| Source of record | UK Trials |
| ISRCTN | ISRCTN61438620 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ET2000/03 (EE99) |
| Public title | EURO-EWING 99: European Ewing Tumour Working Initiative of National Groups |
| Scientific title | Combination chemotherapy with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma |
| Acronym | EURO-EWING 99 |
| Disease/condition/study domain | Ewing's sarcoma |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Netherlands, New Zealand, Portugal, Switzerland, United Kingdom, United States of America, |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | Does not comply with above inclusion criteria |
| Patient information material |
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| Anticipated start date | 01/02/2001 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 1200 |
| Interventions | 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) |
| 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 |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/16572419 |
| Sources of funding | United Kingdom Children's Cancer Study Group (UK) |
| Sponsor name | United Kingdom Children's Cancer Study Group (UK) |
| Sponsor details | University of Leicester 3rd floor Hearts of Oak House 9 Princess Road West Leicester United Kingdom LE1 6HT |
| Sponsor website | http://www.ukccsg.org |
| Contact name | Dr - - |
| Contact details | UKCCCR 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 email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61438620 |
| Date last extracted from ISRCTN register | 17/04/2008 |