Chemotherapy-induced Necrosis in Ewing Sarcoma

Ewing Sarcoma of Bone Clinical Trial

Official title:

Chemotherapy-induced Necrosis in Ewing Sarcoma: Which is the Best Scoring Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968471
• Other study ID #: EW-score
• Status: Completed
• Start date: May 13, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: January 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ewing Sarcoma of Bone
• Necrosis
• Sarcoma
• Sarcoma, Ewing

Intervention

Behavioral:
• Scoring 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.

Locations

Country	Name	City	State
Italy	Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Köhler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jürgens H; European Intergroup Cooperativ — View Citation

Picci P, Böhling 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 — View 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. Ep — 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline (Day0)