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出境医 / 临床实验 / Chemotherapy-induced Necrosis in Ewing Sarcoma

Chemotherapy-induced Necrosis in Ewing Sarcoma

Study Description
Brief Summary:
This is single institution cases series review of histological and clinical data

Condition or disease Intervention/treatment
Ewing Sarcoma of Bone Behavioral: Scoring tool in Chemotherapy-induced necrosis in Ewing sarcoma

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
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 474 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Chemotherapy-induced Necrosis in Ewing Sarcoma: Which is the Best Scoring Tool
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 15, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. retrospective analysis of cases of Ewing sarcomas [ Time Frame: at baseline (Day0) ]
    Investigators will exam the histological response to chemotherapy in localized Ewing sarcoma of bone and correlate it to clinical outcome.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 24, 2019
First Posted Date May 30, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date May 13, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2019) 		retrospective analysis of cases of Ewing sarcomas [ Time Frame: at baseline (Day0) ]
Investigators will exam the histological response to chemotherapy in localized Ewing sarcoma of bone and correlate it to clinical outcome.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chemotherapy-induced Necrosis in Ewing Sarcoma
Official Title Chemotherapy-induced Necrosis in Ewing Sarcoma: Which is the Best Scoring Tool
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Ewing Sarcoma of Bone
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.
Study Groups/Cohorts Not Provided
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.
  • 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.
  • 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:JCO2018782516. doi: 10.1200/JCO.2018.78.2516. [Epub ahead of print]
  • 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 tumor necrosis as a prognostic factor in localized Ewing's sarcoma of the extremities. J Clin Oncol. 1997 Apr;15(4):1553-9.
  • 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 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 21, 2020) 		474
Original Estimated Enrollment
 (submitted: May 29, 2019) 		500
Actual Study Completion Date January 15, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968471
Other Study ID Numbers EW-score
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alberto Righi, Istituto Ortopedico Rizzoli
Study Sponsor Istituto Ortopedico Rizzoli
Collaborators Not Provided
Investigators
Principal Investigator: Alberto Righi, MD Istituto Ortopedico Rizzoli IRCCS
PRS Account Istituto Ortopedico Rizzoli
Verification Date January 2020

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