Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
03/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes