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CompletedNCT03968471Updated Jan 22, 2020

Chemotherapy-induced Necrosis in Ewing Sarcoma

An observational study in Ewing Sarcoma of Bone, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
474
Sex
All
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Study summary

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

Read the 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

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Conditions studied

  • Ewing Sarcoma of Bone
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 474 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Retrospective
Enrollment
474 participants (actual)
Patient registry
No

Interventions

  • BehavioralScoring tool in Chemotherapy-induced necrosis in Ewing sarcoma

    The aim of the present study is to evaluate which is the best scoring tool to determine the histological response to chemotherapy in localized Ewing sarcoma of bone. The study will exam all the different systems to evaluate the histological necrosis after neo-adjuvant chemotherapy in all patients with localized Ewing sarcomas of bone surgically treated between 1982 and 2012.

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What researchers measure

Primary outcomes

  1. retrospective analysis of cases of Ewing sarcomas

    Investigators will exam the histological response to chemotherapy in localized Ewing sarcoma of bone and correlate it to clinical outcome.

    Time frame: at baseline (Day0)

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Study locations

1 site
  • Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
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References and documents

Publications

  • 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. PubMed 18525458 ↗
  • 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. PubMed 20404250 ↗
  • 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 ↗
  • 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. PubMed 9193352 ↗
  • 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. PubMed 18802150 ↗

Study documents

  • Study protocol · Mar 8, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03968471
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Alberto Righi (Principal Investigator, Istituto Ortopedico Rizzoli) — Principal investigator
First posted
May 30, 2019
Start date
May 13, 2019
Primary completion
Dec 31, 2019
Completion
Jan 15, 2020
Last update
Jan 22, 2020

Study contacts

Alberto Righi, MD
principal investigator · Istituto Ortopedico Rizzoli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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