|
ISRCTN
|
ISRCTN59589587
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A European Intergroup Cooperative Ewing's Sarcoma Study: A randomised study for the treatment of Ewing's sarcoma of bone
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
ET 9302
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Bone cancer
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Patients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible
|
|
Anticipated start date
|
01/01/1994
|
|
Anticipated end date
|
30/06/1999
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
1. Cancer Research UK
2. European Community (BIOMED)
3. Deutsche Krebshilfe
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
27/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|
