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Ewing's Sarcoma (ES)Phase 2EW-2NCT02727387

Protocol for the Treatment of Metastatic Ewing Sarcoma

A Phase 2 study testing TEMIRI, ADM and IFO in people with Ewing's Sarcoma (ES), run by Italian Sarcoma Group at 13 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy. Read more about this study

Who is it for?
Ages Up to 40 years
Conditions the study is for
Ewing's Sarcoma (ES)
What is being tested?
TEMIRI, ADM and IFO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
13 sitesItaly
Study dates
1 Jun 2009to 29 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Italy13 sites

  • Centro di Riferimento Oncologico - Unit of Medical Oncology

    Aviano, Pordenone, 33081

  • Azienda ospedaliero universitaria consorziale policlinico - bari

    Bari, 70124

  • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

    Bologna, 40136

  • Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8

    Cagliari, Rosamaria

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

    Candiolo, Torino, 10060

  • A.O. Universitaria Meyer

    Florence, 50139

  • Istituto Giannina Gaslini

    Genova

  • Fondazione IRCCS INT Milano

    Milan

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Ospedale Pediatrico Bambin Gesu'

    Roma

  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

    Torino, 10126

  • IRCCS materno infantile Burlo Garofolo

    Trieste, 34137

Other trials in Italy

About this study

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

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

Read the 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

Being tested
TEMIRI, ADM, IFO, CYC, ETO
Medical subject headings
Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEMIRIDrug

    Also called Temozolomide + Irinotecan

    Window therapy frontline for VHR patients

  • ADMDrug

    Also called Adriamycin

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

  • IFODrug

    Also called Ifosfamide

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

  • CYCDrug

    Also called Cyclophosphamide

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

  • ETODrug

    Also called Etoposide

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

  • BUMELDrug

    Also called busulfan + melphalan

    Consolidation phase

  • VINDrug

    Also called Vincristine

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

Study groups in NCT02727387
Study groupRoleWhat they receive
TEMIRI+VIN+ADM+IFO+ CYC+ETO+BUMELExperimental2cycles 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)
Receives: Drug: TEMIRI; Drug: ADM; Drug: IFO; Drug: CYC; Drug: ETO; Drug: BUMEL; Drug: VIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Evaluation of the OS in patients treated according to the protocol

    Measured: Expected average 3 year

  2. 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

    Measured: Expected average 1 year

Secondary outcomes (3)

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

    Incidence and grade of treatment-emergent Adverse Events

    Measured: every 21 days up to 1 year

  2. 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

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

  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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2016 (estimated)
  2. Study start1 Jun 2009
  3. Primary completion29 Apr 2022
  4. Study completion29 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727387
Sponsor's protocol ID
ISG/AIEOP EW-2
Acronym
EW-2
Status last verified
Sep 2022
First submitted
23 Mar 2016
Last updated
19 Sep 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9193352

  • 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.

    PubMed 18246113

  • 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.

    PubMed 9602261

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TEMIRI, ADM and IFO in people with Ewing's Sarcoma (ES), run by Italian Sarcoma Group at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Expected average 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727387, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.

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