Protocol for the Treatment of Metastatic Ewing Sarcoma

Italian Sarcoma Group155 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Ewing's Sarcoma (ES)

Interventions

TEMIRIDRUG

Window therapy frontline for VHR patients

ADMDRUG

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

IFODRUG

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

Eligibility

Sex: ALLMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (13)

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy

I.R.C.C. - Unit of Medical Oncology

Candiolo, Torino, Italy

Azienda ospedaliero universitaria consorziale policlinico - bari

Bari, Italy

Outcomes

Primary Outcomes

Overall Survival (OS)

Evaluation of the OS in patients treated according to the protocol

Time frame: Expected average 3 year

Event Free Survival (DFS)

Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol

Time frame: Expected average 1 year

Secondary Outcomes

Safety - Incidence and grade of treatment-emergent Adverse Events

Incidence and grade of treatment-emergent Adverse Events

Time frame: 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

Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using PedQL

Time frame: 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

Evaluation of patient's Quality of life: comparison of the Baseline and On treatrment quality of life score using EORTC QLQ-C30

Time frame: every 3 weeks for the first 6 months and 3 monthly up to 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.