Clinical trial NCT03968471: Chemotherapy-induced Necrosis in Ewing Sarcoma
Official title: Chemotherapy-induced Necrosis in Ewing Sarcoma: Which is the Best Scoring Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ewing Sarcoma of Bone
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 474
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients surgically treated at Rizzoli Institute from 01 Jan 1982 to 31 Dic 2012 with diagnosis of Ewing sarcoma

Brief summary: This is single institution cases series review of histological and clinical data

Detailed description: Investigators will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1982 to 31 Dic 2012

Eligibility criteria: Inclusion Criteria:

1. Male and female patients surgically treated at Rizzoli Institute from 01 Jan 1982 to 31 Dic 2012
2. Patients with diagnosis of Ewing sarcoma of bone who have had neo-adjuvant chemotherapy
3. Diagnosis of Ewing sarcoma localized

Exclusion Criteria:

1. Metastatic disease at presentation
2. Soft tissue origin
3. Radiotherapy before surgery

Primary outcomes:
measure: retrospective analysis of cases of Ewing sarcomas
timeFrame: at baseline (Day0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli IRCCS
name: Alberto Righi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esiashvili N, Goodman M, Marcus RB Jr. Changes in incidence and survival of Ewing sarcoma patients over the past 3 decades: Surveillance Epidemiology and End Results data. J Pediatr Hematol Oncol. 2008 Jun;30(6):425-30. doi: 10.1097/MPH.0b013e31816e22f3.
citation: Smith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O'Leary M, Smith FO, Reaman GH. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol. 2010 May 20;28(15):2625-34. doi: 10.1200/JCO.2009.27.0421. Epub 2010 Apr 19.
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.
citation: Picci P, Bohling T, Bacci G, Ferrari S, Sangiorgi L, Mercuri M, Ruggieri P, Manfrini M, Ferraro A, Casadei R, Benassi MS, Mancini AF, Rosito P, Cazzola A, Barbieri E, Tienghi A, Brach del Prever A, Comandone A, Bacchini P, Bertoni F. Chemotherapy-induced tumor necrosis as a prognostic factor in localized Ewing's sarcoma of the extremities. J Clin Oncol. 1997 Apr;15(4):1553-9. doi: 10.1200/JCO.1997.15.4.1553.
citation: Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Kohler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jurgens H; European Intergroup Cooperative Ewing's Sarcoma Study-92. Results of the EICESS-92 Study: two randomized trials of Ewing's sarcoma treatment--cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients. J Clin Oncol. 2008 Sep 20;26(27):4385-93. doi: 10.1200/JCO.2008.16.5720.