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Completed

NCT Number: NCT02727387

Protocol for the Treatment of Metastatic Ewing Sarcoma

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

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Key information

Conditions

Ewing's Sarcoma (ES) Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Sarcoma, Ewing

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro di Riferimento Oncologico - Unit of Medical Oncology, Aviano, Pordenone, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEMIRI

Drug

Window therapy frontline for VHR patients

Other names: Temozolomide + Irinotecan

ADM

Drug

Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide

Other names: Adriamycin

IFO

Drug

Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide

Other names: Ifosfamide

CYC

Drug

Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide

Other names: Cyclophosphamide

ETO

Drug

Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin

Other names: Etoposide

BUMEL

Drug

Consolidation phase

Other names: busulfan + melphalan

VIN

Drug

Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide

Other names: Vincristine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Registry information

Official study title

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

Acronym: EW-2

Important dates

Study start
2009
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2016
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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