Condition category
Cancer
Date applied
29/03/2010
Date assigned
22/04/2010
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ewing sarcoma is a rare type of bone cancer. It is treated with chemotherapy to kill the cancer cells. The aim of this study is to compare a prolonged chemotherapy treatment and a shorter dose-intense chemotherapy treatment for Ewing sarcoma.

Who can participate?
Patients aged under 41 with non-metastatic Ewing sarcoma (i.e., that has not spread)

What does the study involve?
Participants are randomly allocated to receive either the prolonged treatment or the shorter dose-intense treatment. The survival rate in both groups is assessed after four years.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Italian Sarcoma Group (Italy)

When is the study starting and how long is it expected to run for?
April 2009 to April 2016

Who is funding the study?
Italian Sarcoma Group (Italy)

Who is the main contact?
Dr Stefano Ferrari
stefano.ferrari@ior.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefano Ferrari

ORCID ID

Contact details

Via Pupilli 1
Bologna
40136
Italy
-
stefano.ferrari@ior.it

Additional identifiers

EudraCT number

2008-008361-35

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled phase III trial of patients with non-metastatic Ewing sarcoma treated with either a prolonged treatment or a shorter dose-intense treatment and the effect on probability of survival

Acronym

ISG/AIEOP EW-1

Study hypothesis

ISG/AIEOP EW-1 is a randomised phase III trial. The hypothesis tested is that the same probability of survival expected with a prolonged treatment can be achieved with a shorter and dose/intense treatment.

Ethics approval

Ethics board of the Istituto Ortopedico Rizzoli, Bologna, Italy, 17/12/2008, EudraCT no.: 2008-008361-35

Study design

Randomised controlled phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact annalisa.nobile@ior.it to request a patient information sheet

Condition

Non-metastatic Ewing sarcoma

Intervention

Standard arm and experimental arm are based on neoadjuvant chemotherapy. According to the histologic or radiographic response to primary chemotherapy patients will receive high-dose chemotherapy and peripheral stem cells transplantation.

Standard arm:
Alternating cycles with VAC (vincristine 1.5 mg/m^2 [top dose 2 mg], doxorubicin 80 mg/m^2, cyclophosphamide 1,200 mg/m^2), IVAc (ifosfamide 9 g/m^2, vincristine 1.5 mg/m^2 [top dose 2 mg], dactinomycin 1.5 mg/m^2 [top dose 2 mg]), IE (ifosfamide 9 g/m^2, etoposide 450 mg/m^2). In poor responder patients mobilising cycle with CE (cyclophosphamide 4,000 mg/m^2, etoposide 600 mg/m^2), high dose chemotherapy with busulfan (0.8 mg/kg x 4/day for 4 days) and melfalan (140 mg/m^2). Total duration of treatment: good responders 37 weeks, poor responders 25 weeks.

Experimental arm:
Alternating cycles with VAI (vincristine 1.5 mg/m^2 [top dose 2 mg], doxorubicin 80 mg/m^2, ifosfamide 9 g/m^2), IVAc (ifosfamide 9 g/m^2, vincristine 1.5 mg/m^2 [top dose 2 mg]), IE (ifosfamide 9 g/m^2, etoposide 450 mg/m^2). In poor responder patients mobilising cycle with CE (cyclophosfamide 4,000 mg/m^2, etoposide 600 mg/m^2), high dose chemotherapy with busulfan intravenous (I.V.) (0.8 mg/kg x 4/day for 4 days) and melfalan (140 mg/m^2). Total duration of treatment: good responders 25 weeks, poor responders 25 weeks.

Total duration of follow-up for all arms: 5 years enrolment, 2 years follow-up.

Intervention type

Drug

Phase

Phase III

Drug names

Vincristine, dactinomycin, doxorubicin, cyclophosfamide, ifosfamide, etoposide, busulfan, melfalan

Primary outcome measures

Overall survival, measured at four years

Secondary outcome measures

1. Event-free survival,measured at four years
2. Percent of patients with good response to primary chemotherapy
3. Received dose/intensity
4. Chemotherapy toxicity

Overall trial start date

11/04/2009

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with non-metastatic Ewing sarcoma
2. Aged less than 41 years, either sex
3. No previous treatment for the disease
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Metastatic Ewing sarcoma
2. Medical contraindications to the protocol drugs

Recruitment start date

11/04/2009

Recruitment end date

30/04/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Via Pupilli 1
Bologna
40136
Italy

Sponsor information

Organisation

Italian Sarcoma Group (Italy)

Sponsor details

c/o Dr Piero Picci
Via Pupilli 1
Bologna
40136
Italy
-
piero.picci@ior.it

Sponsor type

Research organisation

Website

http://www.italiansarcomagroup.org/

Funders

Funder type

Research organisation

Funder name

Italian Sarcoma Group (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/03/2016: Plain English summary added.