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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list