SIOP RANDOMET 2017

Prior treatment

• other chemotherapy prior to enrolment
• Treated by any investigational agent in a clinical study within previous 4 weeks

Other illness

• pre-existing health impairment that significantly hazards the safe treatment according to the study
• 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)
• any other medical condition incompatible with the protocol treatment
• 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).

Age

• age at start of treatment <3 months or >18 years

Other

• Patient and/or parental/legal representative(s) denied randomization
• unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed
• participation in other interventional trials (registration in observational noninterventional studies is acceptable)
• primary nephrectomy
• inability to be followed until two years after treatment
• 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

• 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.