A European Intergroup Cooperative Ewing's Sarcoma Study: A randomised study for the treatment of Ewing's sarcoma of bone

ISRCTN ISRCTN59589587
DOI https://doi.org/10.1186/ISRCTN59589587
ClinicalTrials.gov number NCT00002516
Secondary identifying numbers ET 9302
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
01/02/2012
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

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBone cancer
InterventionThe trial is divided into two separate studies for standard risk and high risk patients. Following randomisation all patients receive induction chemotherapy with vincristine, adriamycin and ifosfamide alternating every 3 weeks with vincristine, actinomycin-D and ifosfamide (VAIA). A total of four courses, two of each drug combination.

A. STANDARD RISK PATIENTS: Following induction depending upon the initial randomisation patients are allocated to either:
1. Arm A: Chemotherapy with vincristine, adriamycin and cyclophosphamide alternating every 3 weeks with vincristine, actinomycin-D and cyclophosphamide (VACA). A total of ten courses, five of each drug combination.
2. Arm B: Chemotherapy with vincristine, adriamycin and ifosfamide alternating every 3 weeks with vincristine, actinomycin-D and ifosfamide (VAIA), a total of ten courses, five of each drug combination.

B. HIGH RISK PATIENTS: Following induction depending upon the initial randomisation patients are allocated to either:
1. Arm B: Chemotherapy, VAIA as described in Arm B for standard risk patients.
2. Arm C: Chemotherapy etoposide, vincristine, adriamycin and ifosfamide alternating every 3 weeks with etoposide, vincristine, actinomycin-D and ifosfamide (EVAIA). A total of ten courses, five of each drug combination.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cancer drugs
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1994
Completion date30/06/1999

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Biopsy proven Ewing's sarcoma, atypical Ewing's sarcoma or peripheral neuroectodermal tumour
2. No previous radiotherapy, chemotherapy or surgery
3. No primary definitive local therapy
4. Aged < 35 years
Key exclusion criteriaPatients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible
Date of first enrolment01/01/1994
Date of final enrolment30/06/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Research organisation

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom
European Community (BIOMED)

No information available

Deutsche Krebshilfe

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article preliminary results 01/07/1999 Yes No
Results article results 01/01/2003 Yes No
Results article results 01/12/2005 Yes No
Results article results 01/04/2008 Yes No
Results article results 20/09/2008 Yes No