EURO-EWING 99: European ewing tumour working initiative of national groups
| ISRCTN | ISRCTN61438620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61438620 |
| ClinicalTrials.gov number | NCT00020566 |
| Secondary identifying numbers | ET2000/03 (EE99) |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Vincristine, dactinomycin, ifosfamide, cyclophosphamide, busulfan, melphalan |
| Primary outcome measure | 1. Event-free survival 2. Overall survival |
| Secondary outcome measures | 1. Feasibility, toxicity, and response at one month following induction therapy 2. Feasibility and toxicity of consolidation regimens at one month following consolidation therapy |
| Overall study start date | 01/02/2001 |
| Completion date | 30/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- Australia
- Austria
- Belgium
- Canada
- Denmark
- England
- France
- Germany
- Ireland
- Netherlands
- New Zealand
- Portugal
- Switzerland
- United Kingdom
- 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
Sponsor information
University of Birmingham
Charity
Charity
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Website | http://www.ukccsg.org |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2010 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| 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 |
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
