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

Gesellschaft für pädiatrische Onkologie und Hämatologie (GPOH)0 个研究点目标入组 864 人开始时间: 2023年4月27日最近更新: 2024年8月19日

试验速览

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•Primary diagnosed and histologically confirmed, localised (SR) or metastatic (HR) Ewing sarcoma or Ewing-like sarcoma of bone and/or soft tissue
•Age and sex:
•Any sex, age >2 and < 50 years by the date of diagnostic biopsy
•Informed consent:
•According to national and GCP guidelines and signed prior to trial entry, the first diagnostic sample can be used for biobanking and molecular analysis, if of appropriate quality. Willingness and ability to comply with scheduled visits and trial procedures are required.
•Haematological parameters*:
•White blood cell count > 2000/µl
•Cardiological parameters*:
•Left ventricular ejection fraction (LVEF) > 40%, shortening fraction (SF) > 28%
•*checked within 45 days from biopsy to the start of protocol treatment
•Contraception:
•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 informed consent form (ICF) until 6 months after the end of treatment.
•iEuroEwing-SR-RT part:
•Primary diagnosed and histologically confirmed, localised (SR) Ewing sarcoma or Ewing-like sarcoma of bone and/or soft tissue and indication for radiotherapy except of whole lung irradiation.

•Treatment of more than one cycle of chemotherapy prior to registration
•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
•iEuroEwing-SR-RT part:
•Patients who receive preoperative RTX
•Patients who receive Brachytherapy
•Patients who have been diagnosed with pleural effusion
•Patients with previous RT in the same region

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