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Ewing Sarcoma of BoneEWOssNCT04845893

Observational Study on Skeletal Ewing's Sarcoma

An observational study of Ewing Sarcoma of Bone, run by Italian Sarcoma Group at 19 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 0 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Ewing Sarcoma of Bone
What is being tested?
Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)
How many people
100 participants
Where
19 sitesItaly
Study dates
1 Jun 2021to 25 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Patients with Ewing's sarcoma of the bone or with Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the Ewings' Tumor Sarcoma family, sarcoma with Capicua Transcriptional Repressor (CIC) rearrangement or sarcoma with BCL6 corepressor (BCOR) rearrangement

Who may be able to join

  • Diagnosis of Ewing's sarcoma of the bone
  • Diagnosis of Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the ETS family, sarcoma with CIC rearrangement or sarcoma with BCOR rearrangement)
  • Diagnosis of extraosseous Ewing's sarcoma for patients
  • Age at diagnosis <50 years
  • Assessment of the extent of the disease at onset in accordance with the European Society of Medical Oncology guidelines
  • Patients or parents oe guardians of minors who have given their written informed consent to participate in the study

Who cannot join

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

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

19 sites in 1 country

Italy19 sites, 19 recruiting

  • Centro di Riferimento Oncologico - Unit of Medical Oncology

    Aviano, Pordenone, 33081

    Maurizio Mascarin, MD, +390434659 ext. 536, mascarin@cro.it

    Maurizio Mascarin, MD

    Recruiting

  • Azienda ospedaliero universitaria consorziale policlinico - bari

    Bari, 70124

    Francesco De Leonardis, MD, 00390805592 ext. 137, francesco.deleonardis@policlinico.ba.it

    Francesco De Leonardis, MD

    Recruiting

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

    Bologna, 40138

    Arcangelo Prete, MD, +390516363 ext. 111, tmoped@aosp.bo.it

    Arcangelo Prete, MD

    Recruiting

  • Istituto ortopedico Rizzoli

    Bologna

    Toni Ibrahim, MD, ND, toni.ibrahim@ior.it

    Recruiting

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

    Candiolo, Torino, 10060

    Sandra Aliberti, MD, +390119933250, sandra.aliberti@ircc.it

    Sandra Aliberti, MD

    Recruiting

  • A.O. Universitaria Meyer

    Florence, 50139

    Angela Tamburini, MD, +3905556 ext. 621, a.tamburini@meyer.it

    Angela Tamburini, MD

    Recruiting

  • Istituto Giannina Gaslini

    Genova

    Carla Manzitti, MD, ND, carlamanzitti@gaslini.org

    Carla Manzitti, MD

    Recruiting

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milan

    Rossella Bertulli, MD, 0039022390 ext. 2804, rossella.bertulli@istitutotumori.mi.it

    Rossella Bertulli, MD

    Recruiting

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milan

    Roberto Luksch, MD, 02.2390 ext. 2648, roberto.luksch@istitutotumori.mi.it

    Roberto Luksch, MD

    Recruiting

  • Azienda Ospedaliera Santobono Pausilipon

    Naples

    Massimo Eraldo Abate, MD, nd, massimo.abate@gmail.com

    Not yet recruiting

  • Azienda Ospedaliera di Padova

    Padova

    Gianni Bisogno, MD, 039049-8211 ext. 461, gianni.bisogno@unipd.it

    Gianni Bisogno, MD

    Recruiting

  • ARNAS P. O. "Civico e Benfratelli"

    Palermo, 90127

    Paolo D'Angelo, MD, 039 091666 ext. 4316, oncoematologia.ped@arnascivico.it

    Recruiting

  • Azienda Ospedaliera Universitaria di Parma

    Parma

    Patrizia Bertolini, MD, ND, PBertolini@ao.pr.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

    Luca Coccoli, MD, 0039050992 ext. 840, l.coccoli@ao-pisa.toscana.it

    Luca Coccoli, MD

    Recruiting

  • Ospedale Pediatrico Bambin Gesu'

    Roma

    Giuseppe Maria Milano, MD, 06 68591 ext. 111, giuseppemaria.milano@opbg.net

    Giuseppe Maria Milano, MD

    Not yet recruiting

  • Istituto Regina Elena - IFO

    Rome, 00100

    Virginia Ferraresi, MD, +39065266919, ferraresi@ifo.it

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

    Alexia Bertuzzi, MD, +390282244540, alexia.bertuzzi@cancercenter.humanitas.it

    Alexia Bertuzzi, MD

    Recruiting

  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

    Torino, 10126

    Franca Fagioli, MD, +39011313 ext. 5447, franca.fagioli@unito.it

    Franca Fagioli, MD

    Recruiting

  • IRCCS materno infantile Burlo Garofolo

    Trieste, 34137

    Marco Rabusin, MD, 0403785 ext. 563, rabusin@burlo.trieste.it

    Marco Rabusin, MD

    Recruiting

Other trials in Italy

About this study

Official title: Observational Study on Treatment of Skeletal Ewing Sarcoma at Diagnosis

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

Read the detailed 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.

Being tested
Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)
Keywords
Ewing Sarcoma
Medical subject headings
Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments

Study groups in NCT04845893
Study groupRoleWhat they receive
Skeletal Ewing SarcomaThis cohort include patients affected by Ewing Sarcoma of bone, referred to participating Institutions.
Receives: Other: Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5 years Event Free Survival (EFS)

    Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

    Measured: 5 years

Secondary outcomes (3)

  1. Overall Survival (OS)

    Time elapsed for the diagnosis to the death for any cause

    Measured: at 5 years

  2. Adverse events related to the treatments in patients with age >21 years at the time of diagnosis

    Number of Participants of age >21 years with Treatment-Related Adverse Events as Assessed by CTCAE v5.0,

    Measured: Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 30 months

  3. To assess baseline clinical and disease-specific factors with possible impact on survival analyses in the subpopulation with Ewing-like sarcoma

    Collection of clinical pathological characteristics at disease presentation/diagnosis

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start1 Jun 2021
  3. Primary completion25 May 2028 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04845893
Sponsor's protocol ID
ISG-EWOss
Acronym
EWOss
Status last verified
Dec 2025
First submitted
12 Apr 2021
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not planned

Publications

  • Riggi N, Suva ML, Stamenkovic I. Ewing's Sarcoma. N Engl J Med. 2021 Jan 14;384(2):154-164. doi: 10.1056/NEJMra2028910. No abstract available.

    PubMed 33497548

  • Casali PG, Bielack S, Abecassis N, Aro HT, Bauer S, Biagini R, Bonvalot S, Boukovinas I, Bovee JVMG, Brennan B, Brodowicz T, Broto JM, Brugieres L, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Dhooge C, Eriksson M, Fagioli F, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gaspar N, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hecker-Nolting S, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kager L, Kasper B, Kopeckova K, Krakorova DA, Ladenstein R, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Morland B, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Strauss SJ, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee, PaedCan and ERN EURACAN. Bone sarcomas: ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv79-iv95. doi: 10.1093/annonc/mdy310. No abstract available.

    PubMed 30285218

  • Gaspar N, Hawkins DS, Dirksen U, Lewis IJ, Ferrari S, Le Deley MC, Kovar H, Grimer R, Whelan J, Claude L, Delattre O, Paulussen M, Picci P, Sundby Hall K, van den Berg H, Ladenstein R, Michon J, Hjorth L, Judson I, Luksch R, Bernstein ML, Marec-Berard P, Brennan B, Craft AW, Womer RB, Juergens H, Oberlin O. Ewing Sarcoma: Current Management and Future Approaches Through Collaboration. J Clin Oncol. 2015 Sep 20;33(27):3036-46. doi: 10.1200/JCO.2014.59.5256. Epub 2015 Aug 24.

    PubMed 26304893

  • Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, Weiss AR. Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-54. doi: 10.1200/JCO.2011.41.5703. Epub 2012 Oct 22.

    PubMed 23091096

  • Ferrari S, Sundby Hall K, Luksch R, Tienghi A, Wiebe T, Fagioli F, Alvegard TA, Brach Del Prever A, Tamburini A, Alberghini M, Gandola L, Mercuri M, Capanna R, Mapelli S, Prete A, Carli M, Picci P, Barbieri E, Bacci G, Smeland S. Nonmetastatic Ewing family tumors: high-dose chemotherapy with stem cell rescue in poor responder patients. Results of the Italian Sarcoma Group/Scandinavian Sarcoma Group III protocol. Ann Oncol. 2011 May;22(5):1221-1227. doi: 10.1093/annonc/mdq573. Epub 2010 Nov 8.

    PubMed 21059639

  • Luksch R, Tienghi A, Hall KS, Fagioli F, Picci P, Barbieri E, Gandola L, Eriksson M, Ruggieri P, Daolio P, Lindholm P, Prete A, Bisogno G, Tamburini A, Grignani G, Abate ME, Podda M, Smeland S, Ferrari S. Primary metastatic Ewing's family tumors: results of the Italian Sarcoma Group and Scandinavian Sarcoma Group ISG/SSG IV Study including myeloablative chemotherapy and total-lung irradiation. Ann Oncol. 2012 Nov;23(11):2970-2976. doi: 10.1093/annonc/mds117. Epub 2012 Jul 5.

    PubMed 22771824

  • Dirksen U, Brennan B, Le Deley MC, Cozic N, van den Berg H, Bhadri V, Brichard B, Claude L, Craft A, Amler S, Gaspar N, Gelderblom H, Goldsby R, Gorlick R, Grier HE, Guinbretiere JM, Hauser P, Hjorth L, Janeway K, Juergens H, Judson I, Krailo M, Kruseova J, Kuehne T, Ladenstein R, Lervat C, Lessnick SL, Lewis I, Linassier C, Marec-Berard P, Marina N, Morland B, Pacquement H, Paulussen M, Randall RL, Ranft A, Le Teuff G, Wheatley K, Whelan J, Womer R, Oberlin O, Hawkins DS; Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators. High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008. J Clin Oncol. 2019 Dec 1;37(34):3192-3202. doi: 10.1200/JCO.19.00915. Epub 2019 Sep 25.

    PubMed 31553693

  • Ladenstein R, Potschger U, Le Deley MC, Whelan J, Paulussen M, Oberlin O, van den Berg H, Dirksen U, Hjorth L, Michon J, Lewis I, Craft A, Jurgens H. Primary disseminated multifocal Ewing sarcoma: results of the Euro-EWING 99 trial. J Clin Oncol. 2010 Jul 10;28(20):3284-91. doi: 10.1200/JCO.2009.22.9864. Epub 2010 Jun 14.

    PubMed 20547982

  • Whelan J, Le Deley MC, Dirksen U, Le Teuff G, Brennan B, Gaspar N, Hawkins DS, Amler S, Bauer S, Bielack S, Blay JY, Burdach S, Castex MP, Dilloo D, Eggert A, Gelderblom H, Gentet JC, Hartmann W, Hassenpflug WA, Hjorth L, Jimenez M, Klingebiel T, Kontny U, Kruseova J, Ladenstein R, Laurence V, Lervat C, Marec-Berard P, Marreaud S, Michon J, Morland B, Paulussen M, Ranft A, Reichardt P, van den Berg H, Wheatley K, Judson I, Lewis I, Craft A, Juergens H, Oberlin O; Euro-E.W.I.N.G.99 and EWING-2008 Investigators. High-Dose Chemotherapy and Blood Autologous Stem-Cell Rescue Compared With Standard Chemotherapy in Localized High-Risk Ewing Sarcoma: Results of Euro-E.W.I.N.G.99 and Ewing-2008. J Clin Oncol. 2018 Sep 6;36(31):JCO2018782516. doi: 10.1200/JCO.2018.78.2516. Online ahead of print.

    PubMed 30188789

Questions about this trial

What is this clinical trial studying?

An observational study of Ewing Sarcoma of Bone, run by Italian Sarcoma Group at 19 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5 years Event Free Survival (EFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04845893, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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