Observational Study on Skeletal Ewing's Sarcoma

Ewing Sarcoma of Bone Clinical Trial

— EWOss  

Official title:

Observational Study on Treatment of Skeletal Ewing Sarcoma at Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845893
• Other study ID #: ISG-EWOss
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: May 25, 2028

Study information

• Verified date: September 2023
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 25, 2028
• Est. primary completion date: May 25, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 49 Years

Eligibility

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 gene with others not of the ETS family, sarcoma with CIC rearrangement or sarcoma with BCOR 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 European Society of Medical Oncology guidelines

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ewing Sarcoma of Bone
• Sarcoma
• Sarcoma, Ewing

Intervention

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

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone
Italy	Azienda ospedaliero universitaria consorziale policlinico - bari	Bari
Italy	A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna	Bologna
Italy	Istituto ortopedico Rizzoli	Bologna
Italy	I.R.C.C. - Unit of Medical Oncology	Candiolo	Torino
Italy	A.O. Universitaria Meyer	Firenze
Italy	Istituto Giannina Gaslini	Genova
Italy	FONDAZIONE IRCCS Istituto Nazionale dei Tumori	Milano
Italy	FONDAZIONE IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Azienda Ospedaliera Santobono Pausilipon	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	ARNAS P. O. "Civico e Benfratelli"	Palermo
Italy	Azienda Ospedaliera Universitaria di Parma	Parma
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Ospedale Pediatrico Bambin Gesu'	Roma
Italy	Istituto Regina Elena - IFO	Rome
Italy	Istituto Clinico Humanitas	Rozzano	MI
Italy	Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology	Torino
Italy	IRCCS materno infantile Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Clin Oncol. 2015 Mar 1;33(7):814. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	Time elapsed for the diagnosis to the death for any cause	at 5 years
Secondary	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,	Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 30 months
Secondary	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	Baseline