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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drugs
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1994
Completion date	30/06/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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