| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN59589587 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | ET 9302 |
| Public title | A European Intergroup Cooperative Ewings Sarcoma Study: A randomised study for the treatment of Ewings sarcoma of bone |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Bone |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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. Patients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible.
5. Aged < 35 years. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 30/06/1999 |
| Status of trial | Completed |
| 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 | Cancer Research UK
European Community (BIOMED)
Deutsche Krebshilfe |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59589587 |
| Date last extracted from ISRCTN register | 17/04/2008 |
