Non-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.
Conditions
Interventions
Trade Name: Doxorubicin
Product Name: Doxorubicin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Doxorubicin
CAS Number: 23214-92-8
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Research and Development Directorate, University Hospitals of Leicester NMS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Absence of any of the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First objective of the study is to make uniform the treatment of NRSTS patients in Europe. Patients will be treated with a risk-adapted multidisciplinary treatment approach. In particular, the protocol aims to investigate, as main objectives: • the survival rates (event-free survival EFS and overall survival OS) and the pattern of treatment failure in patients with synovial sarcoma and adult-type sarcomas • the role of an ifosfamide-doxorubicin regimen in improving the response rate in patients with unresectable (measurable disease) synovial sarcoma and adult-type sarcomas ;Secondary Objective: Secondary objectives will be: • the prospective evaluation of clinical/pathological prognostic factors, in particular: a) the radiological and pathological response to neo-adjuvant treatment, b) the tumour grade, assessed according to the POG and the FNCLCC, and to the new prospective EpSSG grading system • the impact of the omission of adjuvant chemotherapy in patients with low-risk synovial sarcoma (IRS group I, tumour smaller than 5 cm) • the role of adjuvant chemotherapy in IRS group I-II, G3, size > 5 cm adult-type STS patients in improving the metastases-free survival (MRS) and the OS Moreover, the study aims to improve the biological studies and samples collection of these malignancies. ;Primary end point(s): The objectives of the study are: • Event free survival (EFS), measured as time from histological diagnosis (first surgical approach – biopsy or resection – that leads to histological diagnosis) up to an event. Event is defined as: death for all reasons, progression of a residual tumour, relapse following previous complete remission, appearance of a new tumour. Patients without an event at the end of the study or lost to follow up will be censored at the date of last observation. • Local relapse free survival (LRFS), measured as time from histological diagnosis up to local progression or local relapse. Patients without local failure at the en | — |
Countries
Belgium, Ireland, Italy, United Kingdom
Outcome results
None listed