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Protocol for the Treatment of Metastatic Ewing Sarcoma (EW-2)

Primary Purpose

Ewing's Sarcoma (ES)

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
TEMIRI
ADM
IFO
CYC
ETO
BUMEL
VIN
Sponsored by
Italian Sarcoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ewing's Sarcoma (ES)

Eligibility Criteria

undefined - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro di Riferimento Oncologico - Unit of Medical Oncology
  • I.R.C.C. - Unit of Medical Oncology
  • Azienda ospedaliero universitaria consorziale policlinico - bari
  • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
  • Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
  • A.O. Universitaria Meyer
  • Istituto Giannina Gaslini
  • Fondazione IRCCS INT Milano
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero-Universitaria Pisana
  • Ospedale Pediatrico Bambin Gesu'
  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
  • IRCCS materno infantile Burlo Garofolo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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)

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Evaluation of the OS in patients treated according to the protocol
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

Secondary Outcome Measures

Safety - Incidence and grade of treatment-emergent Adverse Events
Incidence and grade of treatment-emergent Adverse Events
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
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

Full Information

First Posted
March 23, 2016
Last Updated
September 16, 2022
Sponsor
Italian Sarcoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT02727387
Brief Title
Protocol for the Treatment of Metastatic Ewing Sarcoma
Acronym
EW-2
Official Title
Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2009 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Sarcoma Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing's Sarcoma (ES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMEL
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
TEMIRI
Other Intervention Name(s)
Temozolomide + Irinotecan
Intervention Description
Window therapy frontline for VHR patients
Intervention Type
Drug
Intervention Name(s)
ADM
Other Intervention Name(s)
Adriamycin
Intervention Description
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
Intervention Type
Drug
Intervention Name(s)
IFO
Other Intervention Name(s)
Ifosfamide
Intervention Description
Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
Intervention Type
Drug
Intervention Name(s)
CYC
Other Intervention Name(s)
Cyclophosphamide
Intervention Description
Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
Intervention Type
Drug
Intervention Name(s)
ETO
Other Intervention Name(s)
Etoposide
Intervention Description
Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
Intervention Type
Drug
Intervention Name(s)
BUMEL
Other Intervention Name(s)
busulfan + melphalan
Intervention Description
Consolidation phase
Intervention Type
Drug
Intervention Name(s)
VIN
Other Intervention Name(s)
Vincristine
Intervention Description
Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Evaluation of the OS in patients treated according to the protocol
Time Frame
Expected average 3 year
Title
Event Free Survival (DFS)
Description
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 Outcome Measure Information:
Title
Safety - Incidence and grade of treatment-emergent Adverse Events
Description
Incidence and grade of treatment-emergent Adverse Events
Time Frame
every 21 days up to 1 year
Title
Evaluation of Quality of life using Pediatric Quality of Life Inventory (PedQL) -in child and adolescents(EORTC QLQ-C30) for children and adolescents
Description
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
Title
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
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Luksch, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro di Riferimento Oncologico - Unit of Medical Oncology
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
I.R.C.C. - Unit of Medical Oncology
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Azienda ospedaliero universitaria consorziale policlinico - bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8
City
Cagliari
ZIP/Postal Code
Rosamaria
Country
Italy
Facility Name
A.O. Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Istituto Giannina Gaslini
City
Genova
Country
Italy
Facility Name
Fondazione IRCCS INT Milano
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Pediatrico Bambin Gesu'
City
Roma
Country
Italy
Facility Name
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
IRCCS materno infantile Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9193352
Citation
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.
Results Reference
background
PubMed Identifier
18246113
Citation
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.
Results Reference
background
PubMed Identifier
9602261
Citation
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.
Results Reference
background

Learn more about this trial

Protocol for the Treatment of Metastatic Ewing Sarcoma

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