EUCTR2016-001784-36-DE进行中（未招募）1 期
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin - MAKEI V
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
- •Note: Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial treatment and until at least 12 months after end of therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
- •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)
研究者
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