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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 : Recruiting
First Posted : April 4, 2016
Last Update Posted : April 11, 2018
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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Study Start Date : May 2009
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2020


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. Quality of life [ Time Frame: every 3 weeks for the first 6 months and 3 monthly up to 1 year ]
    Evaluation of patient's quality of life: data will be collected by using specific oncologic Quality of Life instruments



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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
Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology Not yet recruiting
Aviano, Pordenone, Italy, 33081
Contact: Maurizio Mascarin, MD    +390434659 ext 536    mascarin@cro.it   
Principal Investigator: Maurizio Mascarin, MD         
I.R.C.C. - Unit of Medical Oncology Recruiting
Candiolo, Torino, Italy, 10060
Contact: Massimo Aglietta, MD    +39.011.9933 ext 628    massimo.aglietta@ircc.it   
Principal Investigator: Massimo Aglietta, MD         
Sub-Investigator: Giovanni Grignani, MD         
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors Recruiting
Bologna, Italy, 40136
Contact: Stefano Ferrari, MD    +390516366199 ext 199    stefano.ferrari@ior.it   
Principal Investigator: Stefano Ferrari, MD         
Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8 Recruiting
Cagliari, Italy, Rosamaria
Contact: Rosamaria Mura, MD    +39070504208      
Principal Investigator: Rosamaria Mura, MD         
A.O. Universitaria Meyer Recruiting
Firenze, Italy, 50139
Contact: Angela Tamburini, MD    +3905556 ext 621    a.tamburini@meyer.it   
Principal Investigator: Angela Tamburini, MD         
Istituto Giannina Gaslini Recruiting
Genova, Italy
Contact: Carla Manzitti, MD    0105636 2431      
Principal Investigator: Carla Manzitti, MD         
Fondazione IRCCS INT Milano Recruiting
Milano, Italy
Contact: Rossella Bertulli, MD    +390223903 ext 287    rossella.bertulli@istitutotumori.mi.it   
Principal Investigator: Rossella Bertulli, MD         
Fondazione IRCCS INT Milano Recruiting
Milano, Italy
Contact: Roberto Luksch, MD    +390223903      
Principal Investigator: Roberto Luksch, MD         
Ospedale Pediatrico Bambin Gesu' Recruiting
Roma, Italy
Contact: Raffaele Cozza, MD    +39065266919      
Principal Investigator: Raffaele Cozza, MD         
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology Recruiting
Torino, Italy, 10126
Contact: Franca Fagioli, MD    +39.011.3135 ext 230    franca.fagioli@unito.it   
Principal Investigator: Franca Fagioli, MD         
Sponsors and Collaborators
Italian Sarcoma Group

Additional Information:
Publications:
Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02727387     History of Changes
Other Study ID Numbers: ISG/AIEOP EW-2
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Cyclophosphamide
Busulfan
Temozolomide
Ifosfamide
Isophosphamide mustard
Irinotecan
Etoposide phosphate
Liposomal doxorubicin
Etoposide
Vincristine
Doxorubicin
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 I Inhibitors