Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00002516
Protocol/serial number
ET 9302
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
30/06/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible
Recruitment start date
01/01/1994
Recruitment end date
30/06/1999
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
ROR
Funders
Funder type
Research organisation
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
European Community (BIOMED)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Deutsche Krebshilfe
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |