Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin - MAKEI V

Medizinische Fakultät der Universität Bonn Rheinische Friedrich-Wilhelms Universität Bonn0 个研究点目标入组 360 人开始时间: 2019年11月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Confirmed extracranial MGCT up to 17 11/12 years of age or patients with ovarian primaries up to 29 11/12 years of age on the date of written informed consent
•Written informed consent prior to trial entry of parents and/or patient
•Diagnosis of a chemotherapy-naïve extracranial MGCT
•Karnofsky-Index of >70% or ECOG-Status 0-II
•Negative pregnancy test within 7 days prior to start of treatment for female patients of childbearing potential, in case of ß-HCG secreting MGCT pregnancy has to be excluded by appropriate methods

•Exclusion criteria in general:
•Pregnancy
•Lactation
•Incomplete data at trial entry preventing risk group allocation
•HIV-positivity
•Live vaccine immunization within two weeks before start of protocol treatment
•Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of chemotherapy
•Current or recent (within 30 days prior to date of informed written consent) treatment with another investigational drug or participation in another interventional clinical trial, except trials with different end points than MAKEI V that can run in parallel to MAKEI V without influencing that trial, e.g., trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc.
•Any other medical, psychiatric or drug related condition, or social condition incompatible with protocol treatment.
•Note: Patients excluded from the trial based on the presence of exclusion criteria may be eligible for registration as follow-up patients. They shall receive adequate treatment and will not be evaluated for primary and secondary objectives.
•Exclusion criteria in special indication:
•Second malignancies
•Negative preoperative tumour markers AFP and ß-HCG and solely pure teratoma histology
•Known hypersensitivity against Cisplatin, Carboplatin, Etoposide, Ifosfamide or other ingredients of the medicinal product
•Hearing impairment Grade 3 and 4 (CTCAE Vers.4.03)

发起方

Medizinische Fakultät der Universität Bonn Rheinische Friedrich-Wilhelms Universität Bonn