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 406 人开始时间: 2020年5月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.
•- 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
•- 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

•- Patient and/or parental/legal representative(s) denied study participation and randomization
•- inability to be followed until two years after treatment
•- primary nephrectomy
•- histology other than nephroblastoma
•- other chemotherapy prior to enrolment
•- 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).
•- any other medical condition incompatible with the protocol treatment
•- 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 non-interventional studies is acceptable)
•- age at start of treatment <3 months or >18 years

发起方

GPOH gGmbH