A European Intergroup Cooperative Ewing's Sarcoma Study: A randomised study for the treatment of Ewing's sarcoma of bone
ISRCTN | ISRCTN59589587 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
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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
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Research organisation
Cancer Research UK
Private sector organisation / Other non-profit organizations
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 | |
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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 | 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 |