Observational Study on Skeletal Ewing's Sarcoma

Last updated: December 19, 2024
Sponsor: Italian Sarcoma Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Treatment

Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)

Clinical Study ID

NCT04845893
ISG-EWOss
  • Ages < 49
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal Ewing Sarcoma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of Ewing's sarcoma of the bone

  2. Diagnosis of Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 genewith others not of the ETS family, sarcoma with CIC rearrangement or sarcoma withBCOR rearrangement)

  3. Diagnosis of extraosseous Ewing's sarcoma for patients

  4. Age at diagnosis <50 years

  5. Assessment of the extent of the disease at onset in accordance with the EuropeanSociety of Medical Oncology guidelines

  6. Patients or parents oe guardians of minors who have given their written informedconsent to participate in the study

Exclusion

Exclusion Criteria:

  1. Presence of comorbid factors who can compromise the compliance of the treatment planor the evaluation of the outcomes, including but not limited to organ pathologiesthat contraindicate the use of chemotherapy and psychological or social conditionsthat do not allow for adequate compliance treatment or adequate follow-up

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
May 25, 2028

Study Description

The Ewing sarcoma treatment is based on chemotherapy, surgery and radiotherapy. Chemotherapy, performed with a combination of several drugs, is given as primary treatment before surgery.

Surgical intervention must be performed in all cases in which it is possible to obtain an excision with free margins and with acceptable functional deficits. However, when, after surgery in case of incomplete resection, post-operative radiotherapy is used, in order to reduce the risk of local recurrence as much as possible.

Subsequently in the local treatment, a phase of maintenance chemotherapy is foreseen, the intensity of which is modulated according to the response to induction therapy.

The treatments are carried out with different programs for patients with localized disease or metastatic disease and derive from clinical trials carried out in the last 30 years.

These results are the result of national and international prospective trials which, precisely due to the rarity of the disease, took many years to execute, and it is significant to know that randomized studies were in very limited numbers, as almost all the studies were represented by studies of uncontrolled phase II Improving treatments requires the expansion of knowledge on the biological behavior of this tumor and the acquisition of as much information as possible deriving from clinical experience.

For this reason, pending the definition of a new prospective randomized trial, which will take time (approximately two years) to be made operational, it is considered useful from a scientific point of view to prospectively collect data relating to new cases of Ewing's sarcoma 'bone.

Connect with a study center

  • Istituto Clinico Humanitas

    Rozzano, MI 20089
    Italy

    Active - Recruiting

  • Centro di Riferimento Oncologico - Unit of Medical Oncology

    Aviano, Pordenone 33081
    Italy

    Active - Recruiting

  • I.R.C.C. - Unit of Medical Oncology

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • Azienda ospedaliero universitaria consorziale policlinico - bari

    Bari, 70124
    Italy

    Active - Recruiting

  • A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Istituto ortopedico Rizzoli

    Bologna,
    Italy

    Active - Recruiting

  • A.O. Universitaria Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini

    Genova,
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Pini

    Milan, 20122
    Italy

    Site Not Available

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Santobono Pausilipon

    Napoli,
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova,
    Italy

    Active - Recruiting

  • ARNAS P. O. "Civico e Benfratelli"

    Palermo, 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Parma

    Parma,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambin Gesu'

    Roma,
    Italy

    Site Not Available

  • Istituto Regina Elena - IFO

    Rome, 00100
    Italy

    Active - Recruiting

  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

    Torino, 10126
    Italy

    Active - Recruiting

  • IRCCS materno infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Active - Recruiting

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