BridgeMD
International Euro Ewing (iEuroEwing) trial for treatment optimisation in patients with Ewing sarcoma
EU CTIS ID: 2022-501180-40-00
What this study is testing
Event-free survival (EFS): iEuroEwing-SR part: The main goal is to conduct a randomised trial part. This will examine, whether the addition of a maintenance treatment using VinoCyc to nine cycles of VDC/IE improves EFS in patients with primary disease, aiming at a 10% increase of a 3-year EFS compared to the standard VDC/IE treatment. iEuroEwing-SR part RT: The main goal is to show in a randomised setting, that a higher RT dose is not inferior regarding an acute skin toxicity CTCAE grade≥3 under RT. The non-inferiority margin for the risk difference is 8% between the combined lower dose and combined higher dose RT arms iEuroEwing-HR part: The main goal is to conduct a randomised trial part. This will examine, whether the addition of a maintenance treatment using VinoCyc to nine cycles of VDC/IE improves EFS in patients with primary disseminated disease, aiming at a 17% increase of 2-year EFS compared to the standard VDC/IE treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically (and molecularly) diagnosed primary localised (SR) or metastatic (HR) Ewing sarcoma or so called Ewing-like sarcoma ( i.e. translocation-positive small blue round cell sarcoma other than Rhabdomyosarcoma) of bone and / or soft tissue; pathological diagnosis can be performed at the investigational site
- Any sex, age >2 and < 50 years by the date of diagnostic biopsy
- Informed consent must be obtained according to national and GCP guidelines and signed prior to trial entry. Subjects and when applicable parental or legal representative(s) must understand and voluntarily provide permission to the ICF, prior to conducting any trial-related assessments / procedures. Willingness and ability to comply with scheduled visits and trial procedures are required.
- White blood cell (WBC) count > 2000/μl*
- Assessment of cardiac function including LVEF > 40% and SF > 28%*
- Serum creatinine < 1.5 X ULN*
You likely can't join if
- Treatment of more than one cycle of chemotherapy prior to registration in the SR group
- Contraindications according to the respective applicable SmPCs
- Additional exclusion criteria iEuroEwing-SR-RT part: Primary diagnosed and histologically confirmed metastatic (HR)
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who receive preoperative RTX
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who receive Brachytherapy
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who have been diagnosed with pleural effusion
See the full eligibility criteria
- Histologically (and molecularly) diagnosed primary localised (SR) or metastatic (HR) Ewing sarcoma or so called Ewing-like sarcoma ( i.e. translocation-positive small blue round cell sarcoma other than Rhabdomyosarcoma) of bone and / or soft tissue; pathological diagnosis can be performed at the investigational site
- Any sex, age >2 and < 50 years by the date of diagnostic biopsy
- Informed consent must be obtained according to national and GCP guidelines and signed prior to trial entry. Subjects and when applicable parental or legal representative(s) must understand and voluntarily provide permission to the ICF, prior to conducting any trial-related assessments / procedures. Willingness and ability to comply with scheduled visits and trial procedures are required.
- White blood cell (WBC) count > 2000/μl*
- Assessment of cardiac function including LVEF > 40% and SF > 28%*
- Serum creatinine < 1.5 X ULN*
- For patients of childbearing potential, a negative pregnancy test must be documented prior to enrolment and repeated every month during therapy. Female and male patients, who are fertile and sexually active, must agree to use an effective form of contraception from the time of signing the ICF until 6 months after the end of treatment. *Parameters must be checked within the screening phase of 45 days from biopsy biopsy / surgery and after diagnosis of metastatic disease to registration.
- Treatment of more than one cycle of chemotherapy prior to registration in the SR group
- Contraindications according to the respective applicable SmPCs
- Additional exclusion criteria iEuroEwing-SR-RT part: Primary diagnosed and histologically confirmed metastatic (HR)
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who receive preoperative RTX
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who receive Brachytherapy
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients who have been diagnosed with pleural effusion
- Additional exclusion criteria iEuroEwing-SR-RT part: Patients with previous RT in the same region
- Concurrent treatment within any other clinical trials, excluding trials with different endpoints, which, due to the nature of their endpoints, must run parallel to iEuroEwing trial, e.g. studies on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc.
- Clinically significant and uncontrolled, or active cardiac disease
- Evidence of invasive fungal infection or other severe systemic infection requiring systemic / parenteral therapy
- Hypersensitivity to the active substance or other excipients contained in the investigational medical products listed in the summary of product characteristics (SmPC) or investigators brochure (IB).
- Secondary malignancy
- Pregnancy or lactation
- Female and male subjects with child-bearing potential, who avoid using highly effective contraceptive methods
- Any other medical, psychiatric, or social condition which is incompatible with the protocol treatment
The study team makes the final eligibility decision.
Where it's taking place
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.