CTIS2023-508926-91-00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) - Randomet2017
GPOH gGmbH0 个研究点目标入组 363 人开始时间: 2024年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 363
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Age <18 years >3 months, Patient 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. Metastatic disease must be confirmed by central review., 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, No pre-existing and ongoing liver function deficiency which is not controllable by substitution, Metastatic childhood renal tumour must be confirmed by central review.
排除标准
- •Patient and/or parental/legal representative(s) denied randomization, pre-existing health impairment that significantly hazards the safe treatment according to the study, 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, Nijmegen Breakage Syndrome), participation in other interventional trials (registration in observational noninterventional studies is acceptable), age at start of treatment <3 months or >18 years, any other medical condition incompatible with the protocol treatment, primary nephrectomy, inability to be followed until two years after treatment, other chemotherapy prior to enrolment, other histology than nephroblastoma at diagnosis, Pregnancy or lactating, Fertile female with child bearing potential and fertile male subjects who deny the use of 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).
研究者
相似试验
招募中
3 期
SIOP RANDOMET 20172023-508926-91-00GPOH gGmbH307
进行中（未招募）
1 期
Randomized phase 3 clinical trial for patients with metastasized childhood renal tumourStage IV childhood renal tumoursEUCTR2018-000533-13-BEGesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH406
招募中
3 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)Metastatic childhood renal tumourC64Malignant neoplasm of kidney, except renal pelvisDRKS00021160GPOH gGmbH406
进行中（未招募）
1 期
Randomized phase 3 clinical trial for patients with metastasized childhood renal tumourStage IV childhood renal tumoursEUCTR2018-000533-13-ATGesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH406
进行中（未招募）
1 期
Randomized phase 3 clinical trial for patients with metastasized childhood renal tumourStage IV childhood renal tumoursEUCTR2018-000533-13-NLGesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH406