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Trial record 1 of 1 for:    NCT02727387
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Protocol for the Treatment of Metastatic Ewing Sarcoma (EW-2)

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ClinicalTrials.gov Identifier: NCT02727387
Recruitment Status : Active, not recruiting
First Posted : April 4, 2016
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

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

Condition or disease Intervention/treatment Phase
Ewing's Sarcoma (ES) Drug: TEMIRI Drug: ADM Drug: IFO Drug: CYC Drug: ETO Drug: BUMEL Drug: VIN Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma
Actual Study Start Date : June 1, 2009
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021


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 Name: Temozolomide + Irinotecan

Drug: ADM
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
Other Name: Adriamycin

Drug: IFO
Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
Other Name: Ifosfamide

Drug: CYC
Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
Other Name: Cyclophosphamide

Drug: ETO
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
Other Name: Etoposide

Drug: BUMEL
Consolidation phase
Other Name: busulfan + melphalan

Drug: VIN
Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide
Other Name: Vincristine




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Expected average 3 year ]
    Evaluation of the OS in patients treated according to the protocol

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727387


Locations
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Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, Italy, 33081
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
Azienda ospedaliero universitaria consorziale policlinico - bari
Bari, Italy, 70124
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
Cagliari, Italy, Rosamaria
A.O. Universitaria Meyer
Firenze, Italy, 50139
Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS INT Milano
Milano, Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
Ospedale Pediatrico Bambin Gesu'
Roma, Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy, 10126
IRCCS materno infantile Burlo Garofolo
Trieste, Italy, 34137
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Principal Investigator: Roberto Luksch, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Additional Information:
Publications:
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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02727387    
Other Study ID Numbers: ISG/AIEOP EW-2
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Cyclophosphamide
Temozolomide
Melphalan
Busulfan
Ifosfamide
Etoposide
Irinotecan
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Topoisomerase I Inhibitors