Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
02/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Bernadette Brennan

ORCID ID

Contact details

Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

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 measures

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

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

http://www.ukccsg.org

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes

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