EUCTR2018-000533-13-NL进行中（未招募）1 期
Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)
Gesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH0 个研究点目标入组 406 人开始时间: 2023年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 406
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
- •- Children <18 years at date of diagnosis and >3months
- •- Patients suffering from metastatic renal tumour at initial diagnosis, having at least one circumscript, non-calcified (pulmonary) nodule (or other lesion highly suspicious of metastasis according to criteria for metastatic disease) =3 mm as determined by chest CT-scan and abdominal CT-scan/MRI (for radiological details please refer to section 12.8).
- •- Metastatic childhood renal tumour must be confirmed by central review.
- •- Signed informed consent form(s) prior to study entry according to national guidelines and GCP guidelines
- •- Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures
- •- Able to adhere to the study visit schedule and other protocol requirements
- •- No pre-existing and ongoing cardiac malfunction disease (insufficiency, malign arrhythmias)
- •- No pre-existing and ongoing liver function deficiency that is not controllable by substitution
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 406
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- inability to be followed until two years after treatment
- •- other chemotherapy prior to enrolment
- •- Patient and/or parental/legal representative(s) denied randomization
- •- primary nephrectomy
- •- histology other than nephroblastoma if confirmed by upfront tumour biopsy/cutting needle biopsy
- •- pregnancy or lactation
- •- Fertile female with child bearing potential and fertile male subjects who refuse using highly effective contraceptive measures
- •- Treated by any investigational agent in a clinical study within previous 4 weeks
- •- hypersensitivity to the active substances or other excipients contained in the investigational medical products listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB).
- •- unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed
- •- inability to receive chemotherapy according to the protocol, this is particulary true for:
- •a.acute kidney failure needing dialysis treatment
- •b.pre-existing peripheral neuropathy
- •- Active, uncontrolled life threatening Infection (e.g. Acute Hepatitis, Pneumonia, AIDS, Varizella)
- •- known chromosomal instability/susceptibility (e.g. Fanconi Anemia, Nejjmegen Breakage Syndrome)
- •- participation in other interventional trials (registration in observational non-interventional studies is acceptable)
- •- age at start of treatment <3 months or >18 years
- •- any other medical condition incompatible with the protocol treatment
研究者
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