Study for rhabdomyosarcoma and other malignant soft tissue tumours of childhood

ISRCTN	ISRCTN15121868
DOI	https://doi.org/10.1186/ISRCTN15121868
ClinicalTrials.gov number	NCT00025441
Secondary identifying numbers	STS9507

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
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 for rhabdomyosarcoma and other malignant soft tissue tumours of childhood
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer, soft tissue
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ifosfamide, vincristine, actinomycin D, carboplatin, epirubicin, etoposide
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/1995
Completion date	31/12/2000

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/1995
Date of final enrolment	31/12/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

United Kingdom Children's Cancer Study Group (UKCCSG) (UK)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2010	21/01/2019	Yes	No

21/01/2019: Publication reference added.