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 (NCT)	NCT00002516
Protocol serial number	ET 9302
Sponsor	Cancer Research UK (CRUK) (UK)
Funders	Cancer Research UK, European Community (BIOMED), Deutsche Krebshilfe

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bone cancer
Intervention	The 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 type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drugs
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex
Key inclusion criteria	1. 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 criteria	Patients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible
Date of first enrolment	01/01/1994
Date of final enrolment	30/06/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes