Compares vincristine-based chemotherapy regimens for children with kidney tumours that have spread
Compares VCE and VAD chemotherapy in children with newly diagnosed spreading kidney tumours.
Plain-language title generated from the registry record
Registry title: SIOP RANDOMET 2017
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with a newly diagnosed kidney tumour that has already spread (stage IV). It compares two chemotherapy combinations given for 6 weeks before surgery.
- Age
- Under 18 years and older than 3 months
- Sex
- All sexes can join
- Disease stage
- Stage IV childhood kidney tumour with at least one spot of spread, such as a lung nodule of 3 mm or more on a scan. The spread must be confirmed by central review.
- Earlier treatment
- No other chemotherapy before joining and no primary nephrectomy (kidney removal surgery). No investigational drug in the previous 4 weeks.
Main reasons for not taking part
- Tumour type other than nephroblastoma at diagnosis
- Existing heart or liver problems that make treatment unsafe
- Acute kidney failure needing dialysis, or existing nerve damage in the limbs (peripheral neuropathy)
- Active, uncontrolled life-threatening infection
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus UniversitetAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- GPOH gGmbH
- Trial code
- EU 2023-508926-91-00
- Record updated
- 7 September 2026
- Original description
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).Read full original descriptionShow less
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)
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).
Inclusion: 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.
Exclusion: other chemotherapy prior to enrolment; Treated by any investigational agent in a clinical study within previous 4 weeks; 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 at start of treatment <3 months or >18 years; 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.