Protocol for the Treatment of Metastatic Ewing Sarcoma (EW-2)

September 16, 2022 updated by: Italian Sarcoma Group

Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma

Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study for the treatment of Ewing metastatic sarcoma with and induction phase with Vincristine (VIN), Adriamycin (ADM), Ciclofosfamide(CYC), Ifosfamide(IFO), Etoposide(ETO) and radiotherapy (RT)followed by a consolidation phase with Busulfan and Melfalan (BUMEL) and Peripheral Blood Stem Cells Transplantation (PBSCT) and a subsequent maintenance phase with Ciclofosfamide and Celecoxib for High Risk (HR) patients.

Very High Risk (VHR) patients will receive a prior frontline therapy with Temozolomide and Irinotecan (TEMIRI), while patient with lung metastasis only will undergo to total lung irradiation after PBSCT

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
      • Cagliari, Italy, Rosamaria
        • Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
      • Firenze, Italy, 50139
        • A.O. Universitaria Meyer
      • Genova, Italy
        • Istituto Giannina Gaslini
      • Milano, Italy
        • Fondazione IRCCS INT Milano
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Roma, Italy
        • Ospedale Pediatrico Bambin Gesu'
      • Torino, Italy, 10126
        • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
      • Trieste, Italy, 34137
        • IRCCS Materno Infantile Burlo Garofolo
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Centro di Riferimento Oncologico - Unit of Medical Oncology
    • Torino
      • Candiolo, Torino, Italy, 10060
        • I.R.C.C. - Unit of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven Ewing's sarcoma
  • Age ≤ 40 years
  • No previous treatment
  • Multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis
  • Signed Informed Consent

Exclusion Criteria:

  • Localized Ewing's sarcoma
  • Any contraindications to the study treatment
  • Female patients who not accept to use an effective birth control method.
  • Pregnant or breast-feeding patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
2cycles of Temozolomide(500 mg/m2)+Irinotecan(250 mg/m2) and 2cycles of Vincristine(1.4mg/m2)+ Adriamycin(90mg/m2)+Ifosfamide (9gr/m2) alternes with 2 cycles of Ciclofosfamide(4g/m2)+Etoposide (600mg/m2) followed by radiotherapy (42-54 Gy) and 2cycles of Ifosfamide (9gr/m2) + Etoposide(300mg/m2) alternes with to 2cycles of Vincristine (1.4mg/m2)+ Adriamycin (80mg/m2)+ Ciclofosfamide(1.2g/m2) and Busulfan(0.8-1.2 mg/Kg)+Melfalan(140 mg/m2)+PBSCT and 6 months with Celecoxib (500mg/m2/die for<14 years old ,800 mg/die for>14 years old) Ciclofosfamide (oral therapy 35mg/m2/die for<14 years old, 50 mg/m2 for>14 years old)
Drug: TEMIRI
Window therapy frontline for VHR patients
Other Names:
  • Temozolomide + Irinotecan
Drug: ADM
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
Other Names:
  • Adriamycin
Drug: IFO
Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
Other Names:
  • Ifosfamide
Drug: CYC
Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
Other Names:
  • Cyclophosphamide
Drug: ETO
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
Other Names:
  • Etoposide
Drug: BUMEL
Consolidation phase
Other Names:
  • busulfan + melphalan
Drug: VIN
Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide
Other Names:
  • Vincristine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Expected average 3 year
Evaluation of the OS in patients treated according to the protocol
Expected average 3 year
Event Free Survival (DFS)
Time Frame: Expected average 1 year
Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol
Expected average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Incidence and grade of treatment-emergent Adverse Events
Time Frame: every 21 days up to 1 year
Incidence and grade of treatment-emergent Adverse Events
every 21 days up to 1 year
Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents
Time Frame: every 3 weeks for the first 6 months and 3 monthly up to 1 year
Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using PedQL
every 3 weeks for the first 6 months and 3 monthly up to 1 year
Evaluation of Quality of life using European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients (EORTC QLQ-C30) for adult patients
Time Frame: every 3 weeks for the first 6 months and 3 monthly up to 1 year
Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using EORTC QLQ-C30
every 3 weeks for the first 6 months and 3 monthly up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Principal Investigator: Roberto Luksch, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2009

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG/AIEOP EW-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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