EURO-EWING 99: European ewing tumour working initiative of national groups
| ISRCTN | ISRCTN61438620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61438620 |
| ClinicalTrials.gov (NCT) | NCT00020566 |
| Protocol serial number | ET2000/03 (EE99) |
| Sponsor | University of Birmingham |
| Funder | Cancer Research UK |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Bernadette Brennan
Scientific
Scientific
Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Combination chemotherapy with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma |
| Study acronym | EURO-EWING 99 |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ewing's sarcoma |
| Intervention | 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) |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Vincristine, dactinomycin, ifosfamide, cyclophosphamide, busulfan, melphalan |
| Primary outcome measure(s) |
1. Event-free survival |
| Key secondary outcome measure(s) |
1. Feasibility, toxicity, and response at one month following induction therapy |
| Completion date | 30/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 1200 |
| Total final enrolment | 1695 |
| Key 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 |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 30/03/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- Australia
- Austria
- Belgium
- Canada
- Denmark
- France
- Germany
- Ireland
- Netherlands
- New Zealand
- Portugal
- Switzerland
- United States of America
Study participating centre
Cancer Research UK Clinical Trials Unit (CRCTU)
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Birmingham
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2006 | Yes | No | |
| Results article | results | 10/07/2010 | Yes | No | |
| Results article | results | 01/09/2015 | Yes | No | |
| Results article | results | 01/10/2017 | Yes | No | |
| Plain English results | 28/03/2019 | 29/10/2021 | No | Yes | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
02/06/2017: The following changes have been made to the record:
1. The Cancer Help UK lay summary link has been corrected
2. The trial website and study contact have been added
3. The funder has been changed from United Kingdom Children's Cancer Study Group to Cancer Research UK
4. Publication references added
