A trial looking at the treatment of children and young people with non-rhabdomyosarcoma soft tissue sarcomas

ISRCTN	ISRCTN55318937
DOI	https://doi.org/10.1186/ISRCTN55318937
EudraCT/CTIS number	2005-001139-31
ClinicalTrials.gov number	NCT00334854
Secondary identifying numbers	2245

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 18/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-treatment-of-children-and-young-people-with-non-rhabdomyosarcoma-soft-tissue-sarcomas

Contact information

Dr Bernadette Brennan
Scientific

Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Study design	Multicentre non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre non-randomised interventional treatment trial looking at the treatment of children and young people with non-rhabdomyosarcoma soft tissue sarcomas
Study acronym	STS 2006 03 (NRSTS)
Study objectives	The protocol comprises three separate sections: synovial sarcoma, adult type sarcoma and other histotypes. In the other histotype section are guidelines for treatment, and for some tumours, more defined treatment plans, however, this should be considered as a suggestion only.
Ethics approval(s)	Trent MREC approved on the 26th September 2005 (ref: 05/MRE04/37)
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Sarcoma, Paediatric Oncology; Disease: Soft Tissue
Intervention	Synovial and adult type sarcoma patients will be treated according to a risk-adapted treatment program. If chemotherapy is given it will be up to 4 cycles (for synovial sarcoma) and 5 cycles (for adult type sarcoma) of ifosfamide-doxorubicin and 2 cycles of ifosfamide alone. Study entry: registration only
Intervention type	Other
Primary outcome measure	Evaluate the survival rates and the pattern of treatment failure, measured after 3 years follow up
Secondary outcome measures	Measured after 3 years follow up: 1. Verify the impact of omission of adjuvant chemotherapy in patients with low-risk synovial sarcoma 2. Investigate the role of adjuvant chemotherapy in IRS group I-II, G3, size greater than 5 cm adult type sarcoma 3. Prospective evaluation of clinical/pathological prognostic factors 4. Investigate the role of ifosfomide-doxorubicin regimen in improving the response rate 5. Unify the treatment of NRSTS patients in Europe
Overall study start date	01/03/2006
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 40; UK sample size: 40
Key inclusion criteria	Eligibility criteria for the prospective non-randomised historically-controlled trial are the following: 1. A pathologically proven diagnosis of synovial sarcoma and adult-type soft tissue sarcomas 2. No evidence of metastatic lesions 3. Age less than 21 years (20 years and 364 days) of age 4. No previous treatment except for primary surgery 5. For patients who require adjuvant chemotherapy according to protocol guidelines, no more than a 8 week-interval between the diagnostic surgical approach and the start of chemotherapy 6. For patients who require adjuvant chemotherapy according to protocol guidelines, no pre-existing illness preventing treatment (in particular renal function must be equivalent to grade 0 - 1 nephrotoxicity, no prior history of cardiac disease and normal shortening fraction [greater than 28%] and ejection fraction [greater than 47%]) 7. No previous malignancy. Patients with post-irradiation soft part sarcomas could be registered and treated according to the protocol guidelines, but they will be analysed separately. 8. Diagnostic material available for pathology review 9. Available for long term follow up through the treatment centre 10. Written informed consent for treatment available
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/03/2006
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Manchester Children's Hospital

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Foundation Trust
Hospital/treatment centre

CMFT Headquarters
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Website	http://www.cmft.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Charity

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

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Central Manchester Unversity Hospitals NHS Foundation Trust

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			18/07/2019	No	Yes

Editorial Notes

18/07/2019: A link to a summary of results was added to the results (plain English).
08/03/2019: No publications found, verifying study status with principal investigator.
26/03/2018: No publications found, verifying study status with principal investigator.
09/02/2016: No publications found, verifying study status with principal investigator.