Observational Study on Skeletal Ewing's Sarcoma

NCT04845893 | Recruiting

• 1 other identifier: ISG-EWOss
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Ewing Sarcoma of Bone

Keywords

Ewing Sarcoma

Outcome Measures

Primary Outcomes (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)

  5 years

Secondary Outcomes (3)

• Overall Survival (OS)

  at 5 years

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

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

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

  Baseline

Study Arms (1)

Skeletal Ewing Sarcoma

This cohort include patients affected by Ewing Sarcoma of bone, referred to participating Institutions.

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

Interventions

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

Skeletal Ewing Sarcoma

Eligibility Criteria

• Age: 0 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (19)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

RECRUITING

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

Candiolo, Torino, 10060, Italy

RECRUITING

Azienda ospedaliero universitaria consorziale policlinico - bari

Bari, 70124, Italy

RECRUITING

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

Bologna, 40138, Italy

RECRUITING

Istituto ortopedico Rizzoli

Bologna, Italy

RECRUITING

A.O. Universitaria Meyer

Florence, 50139, Italy

RECRUITING

Istituto Giannina Gaslini

Genova, Italy

RECRUITING

FONDAZIONE IRCCS Istituto Nazionale dei Tumori

Milan, Italy

RECRUITING

FONDAZIONE IRCCS Istituto Nazionale dei Tumori

Milan, Italy

RECRUITING

Azienda Ospedaliera Santobono Pausilipon

Naples, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Padova

Padua, Italy

RECRUITING

ARNAS P. O. "Civico e Benfratelli"

Palermo, 90127, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Ospedale Pediatrico Bambin Gesu'

Roma, Italy

NOT YET RECRUITING

Istituto Regina Elena - IFO

Rome, 00100, Italy

RECRUITING

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Torino, 10126, Italy

RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 33497548 BACKGROUND

• 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.

  PMID: 30285218 BACKGROUND

• 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.

  PMID: 26304893 BACKGROUND

• 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.

  PMID: 23091096 BACKGROUND

• 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.

  PMID: 21059639 BACKGROUND

• 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.

  PMID: 22771824 BACKGROUND

• 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.

  PMID: 31553693 BACKGROUND

• 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.

  PMID: 20547982 BACKGROUND

• 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.

  PMID: 30188789 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): May 25, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (19)