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EpSSG clinical trials
RMS 2005

EpSSG RMS 2005: a protocol for non metastatic rhabdomyosarcoma

This study is currently recruiting patiens

This protocol addresses the treatment of children and young people presenting with non-metastatic rhabdomyosarcoma.
The protocol contains a randomised trial for “high risk patients” and observational studies for patients categorized in other risk groups.

RATIONALE:
The use of effective drugs combined with surgery and radiotherapy have greatly improved the survival of patients with rhabdomyosarcoma. There is room for improvement, however, and new drug combinations must be experimented to obtain better results in terms of higher survival and/or less toxicity.

OBJECTIVES:
  • To give a homogenous local and systemic treatment Europe-wide according to the risk of relapse in patients categorized in Low, Standard and Very High Risk Groups (observational study)
  • To investigate the role of doxorubicin and maintenance chemotherapy in patients included in the High Risk Group (randomized trial).

    • OUTLINE:
    Patients are subdivided according to the risk factors that have emerged from the analyses of previous European studies. A new stratification has been developed taking into account histology (alveolar vs. non alveolar RMS), post surgical stage, tumour site and size, node involvement and patient’s age.
    According to their risk profile, four Groups have been identified: Low Risk, Standard Risk, High Risk and Very High Risk.
    Different objectives and treatment plans have been elaborated for each group.
  • Patients in the low Risk group will receive chemotherapy according to the VA (vincristine and actinomicin) regimen.
  • Patients in the Standard risk group will receive an IVA (ifosfamide, vincristine and actinomicin) chemotherapy based regimen
  • Patients in the high risk group will receive IVA or IVADo (IVA plus doxorubicin) and after nine cycles will stop the treatment or receive maintenance chemotherapy (vinorelbine and cyclophosphamide)
    • It is expected that 55-60% of patients will be enrolled in the high risk group and will be eligible for the randomized trial.
    ELIGIBILITY:
    A) Observational study
      • Patients with pathologically confirmed rhabdomyosarcoma
      • No evidence of metastatic disease
      • Age 0 - < 21 years
      • Previously untreated except for primary surgery
      • No pre-existing illness preventing treatment
      • No previous malignant tumours.
      • Interval between diagnostic surgery and treatment no longer than 8 weeks
      • Diagnostic material available for pathology review
      • Available for long term follow up through the treatment centre
      • Written informed consent
    B) Investigational study (randomized trial)
      • Patients must satisfy all the eligibility criteria for the observational study
      • Included in the High Risk Group
      • Age > 6 months (younger children will be considered eligible for the observational study but they will not be randomised for treatment)
      • Written informed consent given for the randomised study
    Adults with RMS (> 21 years) may be eligible for registration and treatment on study (according to institutional preference) but not for randomisation.
    Participating Centres
    See the list of EpSSG centres

    More information
    Please refer to the principal investigator and listed EpSSG Centres
     
NRSTS 2005

EpSSG NRSTS 2005: a protocol for Localised Non Rhabdomyosarcoma Soft Tissue Sarcomas

This study is currently recruiting patiens

The NRSTS 2005 protocol addresses the treatment of children and young people affected by non-metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS).
The protocol considers three separate sections: 1) a prospective non-randomized trial for synovial sarcoma, 2) a prospective non-randomized trial for "adult-type" soft tissue sarcomas, 3) general considerations and suggestions for the so-called "other histotypes".

RATIONALE:
This is the first international cooperative protocol completely dedicated to NRSTS. Therefore, first aim of the study is to make uniform the treatment of NRSTS patients in Europe, getting suggestions not only from previous pediatric experience, but also form the large amount of clinical studies concerning adult soft tissue sarcomas. Patients will be treated with a risk-adapted multidisciplinary treatment approach (patients' stratification will be based on surgical stage, tumor size and tumor grade)

OBJECTIVES:
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 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 tumor grade, assessed according to FNCLCC
  • the impact of the omission of adjuvant chemotherapy in patients with low-risk synovial sarcoma (IRS group I, tumor 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

OUTLINE:
The prospective trial on synovial sarcoma recommends the use of ifosfamide-doxorubicin chemotherapy for 3-6 cycles according to a risk-adapted strategy based on the degree of initial surgery and the tumor size at diagnosis. In comparison to previous European protocols, when chemotherapy was required in all synovial sarcoma cases, the current trial suggests the omission of adjuvant chemotherapy in those patients identified as "low-risk" because of complete initial surgery (group I) and tumor smaller than 5 cm. Radiotherapy is required in those patients who cannot be submitted to complete tumor resection.
The group of the so-called "adult-type" soft tissue sarcomas includes fibrosarcoma (adult-type), malignant peripheral nerve sheath tumour, epithelioid sarcoma, leiomyosarcoma, clear cell sarcoma, liposarcoma, alveolar soft part sarcoma, malignant fibrous histiocytoma, hemangiopericytoma (adult-type), angiosarcoma, dermatofibrosarcoma protuberans, mesenchymal chondrosarcoma. The prospective trial stratifies patients according to the degree of first surgery, the tumor grade and the tumor size. Patients with small and low-grade tumors don't require adjuvant chemotherapy in case of histologically complete resection. Chemotherapy and or radiotherapy are suggested when the risk of local or distant relapse is high. In particular, the trial wants to investigate the role of adjuvant chemotherapy in resected high-risk cases (high grade, size > 5 cm), and the role of front-line chemotherapy (ifosfamide-doxorubicin) in improving response rate and final outcome in patients with unresectable disease.

ELIGIBILITY:
Registration is recommended for all patients with diagnosis of NRSTS observed in Pediatric Oncology Center.
Inclusion in the prospective non-randomized historically-controlled trial require:
    • Pathologically proven diagnosis of synovial sacomas or adult-type soft tissue sarcomas
    • Age less than 21 years
    • No evidence of metastatic disease
    • No previous treatment except for primary surgery
    • Diagnostic specimens available for pathological review
    • Written consent

Participating Centres
See the list of EpSSG centres

More information
Please refer to the principal investigator and listed EpSSG Centres