Study for rhabdomyosarcoma and other malignant soft tissue tumours of childhood
| ISRCTN | ISRCTN15121868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15121868 |
| ClinicalTrials.gov (NCT) | NCT00025441 |
| Protocol serial number | STS9507 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK (CRUK) (UK), United Kingdom Children's Cancer Study Group (UKCCSG) (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ifosfamide, vincristine, actinomycin D, carboplatin, epirubicin, etoposide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 18 Years |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | 21/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2019: Publication reference added.
