Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
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

Not specified

Trial type

Not Specified

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

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

United Kingdom Children's Cancer Study Group (UK)

Sponsor details

University of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
Leicester
LE1 6HT
United Kingdom

Sponsor type

Charity

Website

http://www.ukccsg.org

Funders

Funder type

Research organisation

Funder name

United Kingdom Children's Cancer Study Group (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 safety assessment results in http://www.ncbi.nlm.nih.gov/pubmed/16572419

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