Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00020566
Protocol/serial number
ET2000/03 (EE99)
Study information
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
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.
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
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 trial start date
01/02/2001
Overall trial end date
30/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
1200
Participant exclusion criteria
Does not comply with above inclusion criteria
Recruitment start date
01/02/2001
Recruitment end date
30/03/2017
Locations
Countries of recruitment
Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Netherlands, New Zealand, Portugal, Switzerland, United Kingdom, United States of America
Trial participating centre
Cancer Research UK Clinical Trials Unit (CRCTU)
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
01/01/2010
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16572419
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20547982
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26104542
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28436593
Publication citations
-
Safety assessment results
Juergens C, Weston C, Lewis I, Whelan J, Paulussen M, Oberlin O, Michon J, Zoubek A, Juergens H, Craft A, Safety assessment of intensive induction with vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) in the treatment of Ewing tumors in the EURO-E.W.I.N.G. 99 clinical trial., Pediatr Blood Cancer, 2006, 47, 1, 22-29, doi: 10.1002/pbc.20820.