International Euro Ewing (iEuroEwing) trial for treatment optimisation in patients with Ewing sarcoma

Prior treatment

• Treatment of more than one cycle of chemotherapy prior to registration in the SR group
• 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.

Other illness

• 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
• Any other medical, psychiatric, or social condition which is incompatible with the protocol treatment

Other

• 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
• Pregnancy or lactation
• Female and male subjects with child-bearing potential, who avoid using highly effective contraceptive methods

• 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.