| Source of record | UK Trials |
| ISRCTN | ISRCTN15121868 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | STS9507 |
| Public title | Study for rhabdomyosarcoma and other malignant soft tissue tumours of childhood |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Cancer, soft tissue |
| 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. Soft tissue sarcoma at one of the following sites: Vagina - Uterus - Paratestis - Orbit - Head and Neck - Bladder - Prostate - Limbs
2. Histological types: Rhabdomyosarcoma - Embryonal sarcoma - Undifferentiated sarcoma - Extra osseous Ewing's sarcoma - Soft tissue primitive neuroectodermal tumours
3. Stages I and II
4. Aged 6 months to 18 years
5. Less than 8 weeks since diagnostic biopsy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/07/1995 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | High risk non metastatic patients are randomised to one of two treatment groups:
1. Group A: Chemotherapy with ifosfamide, vincristine and actinomycin D (IVA)
2. Group B: Chemotherapy with carboplatin, epirubicin, vincristine, ifosfamide, etoposide and actinomycin D |
| 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
United Kingdom Children's Cancer Study Group (UKCCSG) |
| 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 | ISRCTN15121868 |
| Date last extracted from ISRCTN register | 17/04/2008 |
