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ISRCTN
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ISRCTN15121868
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ClinicalTrials.gov identifier
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Public title
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Study for rhabdomyosarcoma and other malignant soft tissue tumours of childhood
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Scientific title
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Acronym
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N/A
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Serial number at source
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STS9507
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer, soft tissue
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1995
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Anticipated end date
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31/12/2000
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
United Kingdom Children's Cancer Study Group (UKCCSG)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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25/04/2008
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Date ISRCTN assigned
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01/07/2001
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