Condition category
Cancer
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
09/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Bernadette Brennan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2005-001139-31

ClinicalTrials.gov number

NCT00334854

Protocol/serial number

2245

Study information

Scientific title

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

Acronym

STS 2006 03 (NRSTS)

Study hypothesis

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

Trent MREC approved on the 26th September 2005 (ref: 05/MRE04/37)

Study design

Multicentre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 40; UK sample size: 40

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2006

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust

Sponsor details

CMFT Headquarters
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Government

Website

http://www.cmft.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Central Manchester Unversity Hospitals NHS Foundation Trust

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

09/02/2016: No publications found, verifying study status with principal investigator.