European Paediatric Soft Tissue Sarcoma Study Group protocol for Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas 2005 - EpSSG NRSTS

Phase 1

• Conditions: on-rhabdomyosarcoma soft tissue sarcoma. The so called non-rhabdomyosarcoma” soft tissue sarcomas (NRSTS) account for about 3-4% of paediatric cancers and constitute a very heterogeneous group of tumours with a variety of histotypes with different origins, biology and natural history, some of which are more common in adults.

• Registration Number: EUCTR2005-001139-31-GB
• Lead Sponsor: Research and Development Directorate, University Hospitals of Leicester NMS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-09
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Eligibility criteria for the prospective non-randomized historically-controlled trial are the following:

?A pathologically proven diagnosis of synovial sarcoma and adult-type soft tissue sarcomas

?No evidence of metastatic lesions

?Age less than 21 years (20 years and 364 days) of age

?No previous treatment except for primary surgery

?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

?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 [> 28%] and ejection fraction [> 47%])

?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

?Diagnostic material available for pathology review

?Available for long term follow up through the treatment centre

?Written informed consent for treatment available.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Absence of any of the above

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified