Protocol for the Treatment of Metastatic Ewing Sarcoma

NCT02727387 | Completed Phase 2

• 1 other identifier: ISG/AIEOP EW-2
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Ewing's Sarcoma (ES)

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Evaluation of the OS in patients treated according to the protocol

  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

  Expected average 1 year

Secondary Outcomes (3)

• Safety - 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

  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

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

Study Arms (1)

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

EXPERIMENTAL

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; Drug: ADM; Drug: IFO; Drug: CYC; Drug: ETO; Drug: BUMEL; Drug: VIN

Interventions

TEMIRI DRUG

Window therapy frontline for VHR patients

Also known as: Temozolomide + Irinotecan

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

ADM DRUG

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

Also known as: Adriamycin

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

IFO DRUG

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

Also known as: Ifosfamide

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

CYC DRUG

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

Also known as: Cyclophosphamide

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

ETO DRUG

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

Also known as: Etoposide

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

BUMEL DRUG

Consolidation phase

Also known as: busulfan + melphalan

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

VIN DRUG

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

Also known as: Vincristine

TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (13)

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

Location

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

Candiolo, Torino, 10060, Italy

Location

Azienda ospedaliero universitaria consorziale policlinico - bari

Bari, 70124, Italy

Location

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, 40136, Italy

Location

Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8

Cagliari, Rosamaria, Italy

Location

A.O. Universitaria Meyer

Florence, 50139, Italy

Location

Istituto Giannina Gaslini

Genova, Italy

Location

Fondazione IRCCS INT Milano

Milan, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

Location

Ospedale Pediatrico Bambin Gesu'

Roma, Italy

Location

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Torino, 10126, Italy

Location

IRCCS materno infantile Burlo Garofolo

Trieste, 34137, Italy

Location

Related Publications (3)

• Picci P, Bohling T, Bacci G, Ferrari S, Sangiorgi L, Mercuri M, Ruggieri P, Manfrini M, Ferraro A, Casadei R, Benassi MS, Mancini AF, Rosito P, Cazzola A, Barbieri E, Tienghi A, Brach del Prever A, Comandone A, Bacchini P, Bertoni F. Chemotherapy-induced tumor necrosis as a prognostic factor in localized Ewing's sarcoma of the extremities. J Clin Oncol. 1997 Apr;15(4):1553-9. doi: 10.1200/JCO.1997.15.4.1553.

  PMID: 9193352 BACKGROUND

• Gardner SL, Carreras J, Boudreau C, Camitta BM, Adams RH, Chen AR, Davies SM, Edwards JR, Grovas AC, Hale GA, Lazarus HM, Arora M, Stiff PJ, Eapen M. Myeloablative therapy with autologous stem cell rescue for patients with Ewing sarcoma. Bone Marrow Transplant. 2008 May;41(10):867-72. doi: 10.1038/bmt.2008.2. Epub 2008 Feb 4.

  PMID: 18246113 BACKGROUND

• Paulussen M, Ahrens S, Burdach S, Craft A, Dockhorn-Dworniczak B, Dunst J, Frohlich B, Winkelmann W, Zoubek A, Jurgens H. Primary metastatic (stage IV) Ewing tumor: survival analysis of 171 patients from the EICESS studies. European Intergroup Cooperative Ewing Sarcoma Studies. Ann Oncol. 1998 Mar;9(3):275-81. doi: 10.1023/a:1008208511815.

  PMID: 9602261 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

Temozolomide; Irinotecan; Doxorubicin; Ifosfamide; Cyclophosphamide; Etoposide; Busulfan; Melphalan; Vincristine

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Roberto Luksch, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 4, 2016
• Study Start: June 1, 2009
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)