Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00025441
Protocol/serial number
STS9507
Study information
Scientific title
Study for rhabdomyosarcoma and other malignant soft tissue tumours of childhood
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/07/1995
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/07/1995
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
United Kingdom Children's Cancer Study Group (UKCCSG) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20338746 (added 21/01/2019)