ISG/AIEOP EW-1: Randomised controlled trial for patients with non-metastatic Ewing sarcoma
| ISRCTN | ISRCTN50580483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50580483 |
| EudraCT/CTIS number | 2008-008361-35 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2010
- Registration date
- 22/04/2010
- Last edited
- 18/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Via Pupilli 1
Bologna
40136
Italy
| stefano.ferrari@ior.it |
Study information
| Study design | Randomised controlled phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact annalisa.nobile@ior.it to request a patient information sheet |
| 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 |
| Study acronym | ISG/AIEOP EW-1 |
| Study objectives | 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(s) | Ethics board of the Istituto Ortopedico Rizzoli, Bologna, Italy, 17/12/2008, EudraCT no.: 2008-008361-35 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 11/04/2009 |
| Completion date | 30/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Key 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 |
| Key exclusion criteria | 1. Metastatic Ewing sarcoma 2. Medical contraindications to the protocol drugs |
| Date of first enrolment | 11/04/2009 |
| Date of final enrolment | 30/04/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
40136
Italy
Sponsor information
Research organisation
c/o Dr Piero Picci
Via Pupilli 1
Bologna
40136
Italy
| piero.picci@ior.it | |
| Website | http://www.italiansarcomagroup.org/ |
"ROR" |
https://ror.org/01wa16j27 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/03/2016: Plain English summary added.
